Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2022-0593

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3007482

Nom du titulaire (nom légal complet, aucune abbréviation): Bayer CropScience Inc.

Adresse: 160 Quarry Park Boulevard SE Suite 130

Ville: CALGARY

État: AB

Pays: Canada

Code postal /Zip: T2C 3G3

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Incident chez l'humain

4. Date à laquelle le titulaire d'homologation a été informé pour la première fois de l'incident.

13-JUL-21

5. Lieu de l'incident.

Pays: CANADA

État: ALBERTA

6. Date de la première observation de l'incident.

06-JUL-21

Description du produit

7. a) Donner le nom de la matière active et, si disponibles, le numéro d'homologation et le nom du produit (incluant tous les mélanges). Si le produit n'est pas homologué, donner le numéro de la demande d'homologation.

Matière(s) active(s)

---

ARLA No d'homologation 33825      ARLA No de la demande d'homologation       EPA No d'homologation.

Nom du produit: TILMOR EC 240

• Matière active
  • PROTHIOCONAZOLE
  • TEBUCONAZOLE

---

7. b) Type de formulation.

Renseignments sur l'application

8. Est-ce que le produit a été appliqué?

Oui

9. Dose d'application.

Inconnu

10. Site d'application (choisir tout ce qui s'applique).

Site: Res. - Out Home / Rés - à l'ext.maison

11. Donner tout renseignement additionnel concernant l'application (comment le produit a été appliqué, la quantité utilisée, la superficie de la zone traitée, etc.)

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

À être déterminé par le titulaire

12. Selon vous, le produit a-t-il été utilisé en conformité avec le mode d'emploi de L'étiquette?

Oui

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Personne affectée

2. Renseignement démographique sur la personne affectée

Sexe: Femme

Âge: >19 <=64 yrs / >19 <=64 ans

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Oeil
  • Symptôme - Conjonctivite
  • Symptôme - Irritation de l'oeil

• Système gastro-intestinal
  • Symptôme - Enflure de la langue
  • Symptôme - Gorge irritée

• Système respiratoire
  • Symptôme - Autre
  • Specify - Throat Constriction

• Systèmes nerveux et musculaire
  • Symptôme - Mal de tête

• Peau
  • Symptôme - Fourmillement

• Système gastro-intestinal
  • Symptôme - Picotements dans la bouche

• Oeil
  • Symptôme - Oeil rouge

• General
  • Symptôme - Goût de produit chimique dans la bouche

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Inconnu

6. a) Est-ce que la personne a été hospitalisée?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Dérive du pesticide à partir de la zone traitée

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Aucun

10. Voie(s) d'exposition.

Peau

Yeux

Respiratoire

11.Durée de l'exposition?

<=15 min / <=15 min

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

<=30 min / <=30 min

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

7/13/2021 Last week around 7/6/2021 a plane sprayed their yard with the product while she was outside with her family. Caller, her husband, a neighbor, and caller's three children were all exposed to the product via the dermal, ocular, and respiratory routes. Immediately all three of the adults developed a throat constricting sensation, lip/tongue tingling, and eye irritation. Caller and her husband immediately showered, and the symptoms seemed to resolve. However, each time the re-enter the yard they experience the tingling sensation and a headache. Her ocular symptoms have continued intermittently, and her eyes are currently red. Her husband has yet to confirm if his symptoms are still ongoing from being in the yard this morning, but his eyes have remained asymptomatic since the initial exposure. Her oldest child initially developed itching eyes and irritation immediately following the exposure. After showering the symptoms resolved. The following day he experienced a small coughing spell. Since then he has remained asymptomatic. Another child did not report any symptoms. Her youngest child began to have frequent bowel movements and gas which caused him to cry inconsolably the evening of the exposure. He typically has one bowel movement per day. The day after the exposure he had 10 to 12 bowel movements, 8 on the second day, and this gradually improved over the past 5 days. She had the child evaluated by a pediatrician yesterday, who stated that the symptoms were due to a reaction from the exposure. No treatments were performed. No further therapies were used by any of the other exposed persons. Today caller and her husband were in the yard again for about an hour. The both could still taste the product in their mouths. The experienced a headache and their tongues felt thick and tingling immediately after. Each time they go out into the yard, their symptoms return. 7/16/2021 Attempted call back to the original caller. A message was left requesting follow up information.

À être déterminé par le titulaire

14. Classification selon la gravité.

Mineure

15. Donner des renseignements additionnels ici.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Autre

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: >19 <=64 yrs / >19 <=64 ans

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Oeil
  • Symptôme - Irritation de l'oeil

• Système gastro-intestinal
  • Symptôme - Enflure de la langue
  • Symptôme - Gorge irritée

• Systèmes nerveux et musculaire
  • Symptôme - Mal de tête

• Système respiratoire
  • Symptôme - Autre
  • Specify - Throat constriction

• Peau
  • Symptôme - Fourmillement

• Système gastro-intestinal
  • Symptôme - Picotements dans la bouche

• General
  • Symptôme - Goût de produit chimique dans la bouche

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Inconnu

6. a) Est-ce que la personne a été hospitalisée?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Dérive du pesticide à partir de la zone traitée

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Aucun

10. Voie(s) d'exposition.

Peau

Yeux

Respiratoire

11.Durée de l'exposition?

<=15 min / <=15 min

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

<=30 min / <=30 min

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

7/13/2021 Last week around 7/6/2021 a plane sprayed their yard with the product while she was outside with her family. Caller, her husband, a neighbor, and caller's three children were all exposed to the product via the dermal, ocular, and respiratory routes. Immediately all three of the adults developed a throat constricting sensation, lip/tongue tingling, and eye irritation. Caller and her husband immediately showered, and the symptoms seemed to resolve. However, each time the re-enter the yard they experience the tingling sensation and a headache. Her ocular symptoms have continued intermittently, and her eyes are currently red. Her husband has yet to confirm if his symptoms are still ongoing from being in the yard this morning, but his eyes have remained asymptomatic since the initial exposure. Her oldest child initially developed itching eyes and irritation immediately following the exposure. After showering the symptoms resolved. The following day he experienced a small coughing spell. Since then he has remained asymptomatic. Another child did not report any symptoms. Her youngest child began to have frequent bowel movements and gas which caused him to cry inconsolably the evening of the exposure. He typically has one bowel movement per day. The day after the exposure he had 10 to 12 bowel movements, 8 on the second day, and this gradually improved over the past 5 days. She had the child evaluated by a pediatrician yesterday, who stated that the symptoms were due to a reaction from the exposure. No treatments were performed. No further therapies were used by any of the other exposed persons. Today caller and her husband were in the yard again for about an hour. The both could still taste the product in their mouths. The experienced a headache and their tongues felt thick and tingling immediately after. Each time they go out into the yard, their symptoms return. 7/16/2021 Attempted call back to the original caller. A message was left requesting follow up information.

À être déterminé par le titulaire

14. Classification selon la gravité.

Mineure

15. Donner des renseignements additionnels ici.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Autre

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: Unknown / Inconnu

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Oeil
  • Symptôme - Irritation de l'oeil

• Système gastro-intestinal
  • Symptôme - Gorge irritée

• Système respiratoire
  • Symptôme - Autre
  • Specify - Throat Constriction

• Peau
  • Symptôme - Fourmillement

• Système gastro-intestinal
  • Symptôme - Picotements dans la bouche

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Inconnu

6. a) Est-ce que la personne a été hospitalisée?

Inconnu

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Dérive du pesticide à partir de la zone traitée

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Aucun

10. Voie(s) d'exposition.

Peau

Yeux

Respiratoire

11.Durée de l'exposition?

<=15 min / <=15 min

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

<=30 min / <=30 min

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

7/13/2021 Last week around 7/6/2021 a plane sprayed their yard with the product while she was outside with her family. Caller, her husband, a neighbor, and caller's three children were all exposed to the product via the dermal, ocular, and respiratory routes. Immediately all three of the adults developed a throat constricting sensation, lip/tongue tingling, and eye irritation. Caller and her husband immediately showered, and the symptoms seemed to resolve. However, each time the re-enter the yard they experience the tingling sensation and a headache. Her ocular symptoms have continued intermittently, and her eyes are currently red. Her husband has yet to confirm if his symptoms are still ongoing from being in the yard this morning, but his eyes have remained asymptomatic since the initial exposure. Her oldest child initially developed itching eyes and irritation immediately following the exposure. After showering the symptoms resolved. The following day he experienced a small coughing spell. Since then he has remained asymptomatic. Another child did not report any symptoms. Her youngest child began to have frequent bowel movements and gas which caused him to cry inconsolably the evening of the exposure. He typically has one bowel movement per day. The day after the exposure he had 10 to 12 bowel movements, 8 on the second day, and this gradually improved over the past 5 days. She had the child evaluated by a pediatrician yesterday, who stated that the symptoms were due to a reaction from the exposure. No treatments were performed. No further therapies were used by any of the other exposed persons. Today caller and her husband were in the yard again for about an hour. The both could still taste the product in their mouths. The experienced a headache and their tongues felt thick and tingling immediately after. Each time they go out into the yard, their symptoms return. 7/16/2021 Attempted call back to the original caller. A message was left requesting follow up information.

À être déterminé par le titulaire

14. Classification selon la gravité.

Mineure

15. Donner des renseignements additionnels ici.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Autre

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: >6 <=12 yrs / > 6 < = 12 ans

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Oeil
  • Symptôme - Irritation de l'oeil

• Système respiratoire
  • Symptôme - Toux

• Oeil
  • Symptôme - Yeux irrités

4. Quelle a été la durée des symptômes?

>8 hrs <=24 hrs / > 8 h < = 24 h

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Inconnu

6. a) Est-ce que la personne a été hospitalisée?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Dérive du pesticide à partir de la zone traitée

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Aucun

10. Voie(s) d'exposition.

Peau

Yeux

Respiratoire

11.Durée de l'exposition?

<=15 min / <=15 min

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

<=30 min / <=30 min

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

7/13/2021 Last week around 7/6/2021 a plane sprayed their yard with the product while she was outside with her family. Caller, her husband, a neighbor, and caller's three children were all exposed to the product via the dermal, ocular, and respiratory routes. Immediately all three of the adults developed a throat constricting sensation, lip/tongue tingling, and eye irritation. Caller and her husband immediately showered, and the symptoms seemed to resolve. However, each time the re-enter the yard they experience the tingling sensation and a headache. Her ocular symptoms have continued intermittently, and her eyes are currently red. Her husband has yet to confirm if his symptoms are still ongoing from being in the yard this morning, but his eyes have remained asymptomatic since the initial exposure. Her oldest child initially developed itching eyes and irritation immediately following the exposure. After showering the symptoms resolved. The following day he experienced a small coughing spell. Since then he has remained asymptomatic. Another child did not report any symptoms. Her youngest child began to have frequent bowel movements and gas which caused him to cry inconsolably the evening of the exposure. He typically has one bowel movement per day. The day after the exposure he had 10 to 12 bowel movements, 8 on the second day, and this gradually improved over the past 5 days. She had the child evaluated by a pediatrician yesterday, who stated that the symptoms were due to a reaction from the exposure. No treatments were performed. No further therapies were used by any of the other exposed persons. Today caller and her husband were in the yard again for about an hour. The both could still taste the product in their mouths. The experienced a headache and their tongues felt thick and tingling immediately after. Each time they go out into the yard, their symptoms return. 7/16/2021 Attempted call back to the original caller. A message was left requesting follow up information.

À être déterminé par le titulaire

14. Classification selon la gravité.

Mineure

15. Donner des renseignements additionnels ici.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Autre

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: <=1 yr / < = 1 an

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Système gastro-intestinal
  • Symptôme - Autre
  • Specify - Frequent Bowel Movements
  • Symptôme - Distension abdominale

• General
  • Symptôme - Vocalisation

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Non

6. a) Est-ce que la personne a été hospitalisée?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Dérive du pesticide à partir de la zone traitée

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Aucun

10. Voie(s) d'exposition.

Peau

Yeux

Respiratoire

11.Durée de l'exposition?

<=15 min / <=15 min

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

<=30 min / <=30 min

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

7/13/2021 Last week around 7/6/2021 a plane sprayed their yard with the product while she was outside with her family. Caller, her husband, a neighbor, and caller's three children were all exposed to the product via the dermal, ocular, and respiratory routes. Immediately all three of the adults developed a throat constricting sensation, lip/tongue tingling, and eye irritation. Caller and her husband immediately showered, and the symptoms seemed to resolve. However, each time the re-enter the yard they experience the tingling sensation and a headache. Her ocular symptoms have continued intermittently, and her eyes are currently red. Her husband has yet to confirm if his symptoms are still ongoing from being in the yard this morning, but his eyes have remained asymptomatic since the initial exposure. Her oldest child initially developed itching eyes and irritation immediately following the exposure. After showering the symptoms resolved. The following day he experienced a small coughing spell. Since then he has remained asymptomatic. Another child did not report any symptoms. Her youngest child began to have frequent bowel movements and gas which caused him to cry inconsolably the evening of the exposure. He typically has one bowel movement per day. The day after the exposure he had 10 to 12 bowel movements, 8 on the second day, and this gradually improved over the past 5 days. She had the child evaluated by a pediatrician yesterday, who stated that the symptoms were due to a reaction from the exposure. No treatments were performed. No further therapies were used by any of the other exposed persons. Today caller and her husband were in the yard again for about an hour. The both could still taste the product in their mouths. The experienced a headache and their tongues felt thick and tingling immediately after. Each time they go out into the yard, their symptoms return. 7/16/2021 Attempted call back to the original caller. A message was left requesting follow up information.

À être déterminé par le titulaire

14. Classification selon la gravité.

Mineure

15. Donner des renseignements additionnels ici.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.