Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-5453

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3658346

Nom du titulaire (nom légal complet, aucune abbréviation): 2022 ENVIRONMENTAL SCIENCE CA INC.

Adresse: 210-137 GLASGOW STREET

Ville: KITCHENER

État: ON

Pays: CANADA

Code postal /Zip: N2G 4X8

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.

12-JUL-23

5. Lieu de l'incident.

Pays: UNITED STATES

État: ARIZONA

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

Inconnu

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       ARLA No de la demande d'homologation       EPA No d'homologation. 432-1544

Nom du produit: Temprid FX Insecticide (EQUIVALENT TO TEMPRID SC in CANADA)

• Matière active
  • BETA-CYFLUTHRIN
  • IMIDACLOPRID
    • Inconnu

---

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

Nom du produit: Gentrol (non-company)

• Matière active
  • LAMBDA-CYHALOTHRIN

---

7. b) Type de formulation.

Liquide

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. - In Home / Rés. - à l'int. 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?

Non

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

• Système gastro-intestinal
  • Symptôme - Diarrhée
  • Symptôme - Nausée
  • Symptôme - Vomit

• General
  • Symptôme - Diaphorèse
  • Symptôme - Autre
  • Specify - Brain fog

• Système gastro-intestinal
  • Symptôme - Autre
  • Specify - Film in mouth

• Systèmes nerveux et musculaire
  • Symptôme - Mal de tête
  • Symptôme - Anxiété

• Système rénal
  • Symptôme - Polyurie

• Système respiratoire
  • Symptôme - Toux
  • Symptôme - Congestion respiratoire

• Peau
  • Symptôme - Cloque
  • Symptôme - Urticaire
  • Symptôme - Autre
  • Specify - Painful nodules to deep touch

• Système respiratoire
  • Symptôme - Saignement du nez
  • Symptôme - Autre
  • Specify - Film in nose

• Systèmes nerveux et musculaire
  • Symptôme - Engourdissement
  • Specify - Numb to light touch

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.

Oui

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)

Application

Contact avec la zone traitée

Quelle était l'activité? The patient remained in the apartment during treatment.

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

Respiratoire

11.Durée de l'exposition?

>1 yr / > 1 an

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

>6 mos / > 6 mois

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.)

All the following were caller stated: Since 2018 applications recurred every 3 month, in instances sprayed right around her bed while she remained in apartment.PCO changed OCT'18 to another PCO. After 1 year, both started getting anxiety attacks, outbursts. NOV'22, during treatment, hair brush was on counter close totreatment area and she believes it caused development of fluid filled blisters on scalp in DEC'22. Emergency dept. made no diagnosis, told to wash with mildsoap and prescribed antibiotics, but still spread to forehead by JAN'23. Was not followed up to dermatologist, but blisters and fluid filled resolved to leave noduleswhich are painful to deep touch. Latest MAY 25,'23 application, both remained in apart. during appl., not advised to vacate, product was broadcast sprayed, inappl. to bathroom product got on shower curtains and toothbrush. Product got all over mattress, nightstand, dresser, bed frame, clothing and paper etc. aroundroom. PCO did not mention 3 hour non-touch period, done before. She told him to stop and operator left. Both exited, returned few hours later. Upon re-entry -both noted strong odor, opened window and door to ventilate, developed strong headache, felt brain fog, followed by vomiting, development of congestion andcough. Both also had bloody nose and diarrhea. Symptoms persisted and called apprt. manager about concern, was advised to talk to PCO, who denied misuseof product and gave products used in MAY '23. Caller cleaned, with gloves, long sleeves(got wet during). Both developed various symptoms incl. blisters andhives after -caller on arms, necks, buttocks, hands, face; Son's arms, legs, back, buttocks - probably from sitting on couch, treated toilet seat, though no directcontact specified earlier. Treatment with Mg and Benadryl helped, public nurse came but just advised drinking water not touch blisters. She moved approx. JUN7, '23 temporarily, all symptoms since resolved excl. ocassional nausea.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

The product at directed dilution contains less than 0.1% Imidacloprid and less than 0.05% Beta-cyfluthrin depending on chosen dilution rate. The reporter stated product was applied every 3 months before the last application. Applications before also broke label, but one on May 25, 2023 used a 'space spray' application according to the reporter to have occurred, even in bathroom. No direct exposures to wet product was reported at any time. They were told to not touch areas of application for three hours after application and on May 25, 2023, they left the home after application (not asked by PCO) for a few hours. During previous applications, product was applied as a spot treatment and to crack and crevices and is expected to stay where applied, decreasing the chance for exposure to the product. Additionally, once dried, the active ingredients in the product are not expected to transfer from touch or be inhaled. While the reported signs and symptoms have a temporal relationship to the start of product use all other differential diagnoses have not been ruled out and are not consistent with the described exposure to the product. Of note, the reporter has a past medical history significant for COPD, fibromyalgia, arthritis, degenerative disc disease,chronic daily migraines and is a half a pack per day smoker for which she takes albuterol, ondansetron, and nortriptyline. Removal of the product from application areas did not improve symptoms. Additionally, symptoms improved while reporter was no longer living at the residence, but the nausea remained. True re-challenge,complete removal from the product and resolution of symptoms before re-challenging the product, has not occurred. It is unlikely that the reported signs and symptoms are associated with product use.

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: Homme

Âge: >6 <=12 yrs / > 6 < = 12 ans

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

Système

• Système gastro-intestinal
  • Symptôme - Diarrhée
  • Symptôme - Nausée
  • Symptôme - Vomit

• General
  • Symptôme - Diaphorèse
  • Symptôme - Autre
  • Specify - Brain fog

• Système gastro-intestinal
  • Symptôme - Autre
  • Specify - Film in mouth

• Systèmes nerveux et musculaire
  • Symptôme - Mal de tête
  • Symptôme - Anxiété

• Système rénal
  • Symptôme - Polyurie

• Système respiratoire
  • Symptôme - Toux
  • Symptôme - Saignement du nez
  • Symptôme - Congestion respiratoire

• Peau
  • Symptôme - Urticaire

• Système respiratoire
  • Symptôme - Autre
  • Specify - Film in nose

• Peau
  • Symptôme - Cloque

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.

Oui

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)

Application

Contact avec la zone traitée

Quelle était l'activité? The patient remained in the apartment during treatment.

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

Respiratoire

11.Durée de l'exposition?

>1 yr / > 1 an

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

>6 mos / > 6 mois

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.)

All the following were caller stated: Since 2018 applications recurred every 3 month, in instances sprayed right around her bed while she remained in apartment. PCO changed OCT'18 to another PCO. After 1 year, both started getting anxiety attacks, outbursts. NOV'22, during treatment, hair brush was on counter close to treatment area and she believes it caused development of fluid filled blisters on scalp in DEC'22. Emergency dept. made no diagnosis, told to wash with mild soap and prescribed antibiotics, but still spread to forehead by JAN'23. Was not followed up to dermatologist, but blisters and fluid filled resolved to leave nodules which are painful to deep touch. Latest MAY 25,'23 application, both remained in apart. during appl., not advised to vacate, product was broadcast sprayed, in appl. to bathroom product got on shower curtains and toothbrush. Product got all over mattress, nightstand, dresser, bed frame, clothing and paper etc. around room. PCO did not mention 3 hour non-touch period, done before. She told him to stop and operator left. Both exited, returned few hours later. Upon re-entry -both noted strong odor, opened window and door to ventilate, developed strong headache, felt brain fog, followed by vomiting, development of congestion and cough. Both also had bloody nose and diarrhea. Symptoms persisted and called apprt. manager about concern, was advised to talk to PCO, who denied misuse of product and gave products used in MAY '23. Caller cleaned, with gloves, long sleeves(got wet during). Both developed various symptoms incl. blisters and hives after -caller on arms, necks, buttocks, hands, face; Son's arms, legs, back, buttocks - probably from sitting on couch, treated toilet seat, though no direct contact specified earlier. Treatment with Mg and Benadryl helped, public nurse came but just advised drinking water not touch blisters. She moved approx. JUN7, '23 temporarily, all symptoms since resolved excl. ocassional nausea.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

The product at directed dilution contains less than 0.1% Imidacloprid and less than 0.05% Beta-cyfluthrin depending on chosen dilution rate. The reporter stated product was applied every 3 months before the last application. Applications before also broke label, but one on May 25, 2023 used a 'space spray' application according to the reporter to have occurred, even in bathroom. No direct exposures to wet product was reported at any time. They were told to not touch areas of application for three hours after application and on May 25, 2023, they left the home after application (not asked by PCO) for a few hours. During previous applications, product was applied as a spot treatment and to crack and crevices and is expected to stay where applied, decreasing the chance for exposure tothe product. Additionally, once dried, the active ingredients in the product are not expected to transfer from touch or be inhaled. While the reported signs and symptoms have a temporal relationship to the start of product use all other differential diagnoses have not been ruled out and are not consistent with the described exposure to the product. Of note, the reporter has a past medical history significant for COPD, fibromyalgia, arthritis, degenerative disc disease,chronic daily migraines and is a half a pack per day smoker for which she takes albuterol, ondansetron, and nortriptyline. Removal of the product from application areas did not improve symptoms. Additionally, symptoms improved while reporter was no longer living at the residence, but the nausea remained. True re-challenge,complete removal from the product and resolution of symptoms before re-challenging the product, has not occurred. It is unlikely that the reported signs and symptoms are associated with product use.