Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-7144

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3413433

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

Incident chez un animal domestique

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

20-OCT-22

5. Lieu de l'incident.

Pays: UNITED STATES

État: MISSOURI

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)

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

Nom du produit: RoundUp Herbicide

• Matière active
  • GLYPHOSATE
    • Inconnu

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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. - 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?

Inconnu

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: Unknown / Inconnu

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

Système

• Système gastro-intestinal
  • Symptôme - Anorexie
  • Symptôme - Nausée
  • Symptôme - Douleur à l'estomac
  • Symptôme - Vomit

• General
  • Symptôme - Cancer
  • Specify - Chronic Lymphocytic Leukemia Lymphoma
  • Symptôme - Sensation de faiblesse
  • Symptôme - Autre
  • Specify - Fluid filled lymph nodes

• Systèmes nerveux et musculaire
  • Symptôme - Autre
  • Specify - Hernia

• General
  • Symptôme - Autre
  • Specify - Hit head and started bleeding

• Systèmes nerveux et musculaire
  • Symptôme - Évanouissement

• General
  • Symptôme - Faiblesse

• Systèmes nerveux et musculaire
  • Symptôme - Étourdissement
  • Symptôme - Agitation
  • Specify - Jitteriness
  • Symptôme - Inconscience
  • Symptôme - Engourdissement
  • Symptôme - Tremblement

• Système gastro-intestinal
  • Symptôme - Crampes à l'estomac

• Systèmes nerveux et musculaire
  • Symptôme - Collapsus

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

Professionnel

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

Application

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

Empoisonnement par ingestion d'un produit

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)

Chemise à manches longues

10. Voie(s) d'exposition.

Peau

Orale

Respiratoire

Inconnu

11.Durée de l'exposition?

Unknown / Inconnu

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

Unknown / Inconnu

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.)

10/20/2022 All of the following has been spontaneously reported by the caller. Caller is reporting exposure to the product in 2015 and 2017. He would like more information about his diagnosis. He used the product 1-2 times a week as a lawn caretaker for a private customer from April 2015 through June 2015. The customer supplied a ready to use pump spray bottle. He pumped the bottle and applied the product in sweeping side to side motion on the patio. On one occasion, (date unknown) the wind blew the product on his face during application. It got into his pores, nostrils, mouth, and ears. He was wearing gloves (unknown if chemical resistant) and long sleeves at the time of exposure. He finished the application, showered, and changed clothes within 5 hours of exposure. Around the end of March 2015, he developed a jittery feeling. Symptoms escalated and he developed nausea, lack of appetite, vomiting. He went to the hospital by ambulance in 2015 (date unknown). He told them about product exposure. They did unspecified blood work, a colonoscopy, and other unspecified tests. Symptoms continued. He was diagnosed with Chronic Lymphocytic Leukemia Lymphoma in 2017 and has been treated with chemotherapy, antibiotics, and other unspecified medications. He is unsure if he will need more chemo and is working with doctors on how to proceed. He started working for the customer again in August 2017 (after Chronic Lymphocytic Leukemia Lymphoma diagnosis). He applied the same product twice a week while wearing long sleeves and gloves. He states he was exposed to the odor of the product (date unknown). He was able to get fresh air after using the product and had no other exposures at any point. After one occasion of using the product in 2017 (date unknown), he was sitting on a patio bench, passed out, lost consciousness, fell to the ground, hit his head on the concrete and started bleeding. He was transported to the emergency room by ambulance.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Incident report narrative, continued: He also has symptoms of numbness in his fingers, hernia, stomach pain, stomach cramps, dizziness, weakness, faintness, shakiness, and fluid filled lymph node knots that come and go. It is unclear when symptoms started. Caller stated the customers pet died also from the herbicide; however no other information was obtained before consumer disconnected. Caller does not remember exact dates and does not have product label available at the time of call. He remembers the product label saying RoundUp Herbicide. Product identified by name only. Company causality score: 0 (unlikely relationship). As the reporter did not identify a specific product alleged to have caused the exposure, Bayer has chosen to report this exposure using the product in this report using the information it had available, including reported use and market share. This selection may not be accurate due to the lack of information provided by the reporter. A very loose or no temporal relationship exists between the onset of symptoms and the exposures to the product. The symptoms started prior to any exposure to the product. Ready to use RoundUp products have low concentrations of ingredients and the exposures described were minor in nature and few. There is no identifiable plausible explanation for the product to produce or otherwise influence the effects given the described exposures. There are many other differential diagnoses to consider and symptoms have not resolved or improved since removal of the exposure to the product which is typically expected for minor exposures, as described. After review of the available information the product is unlikely correlated with the reported symptoms after product exposure.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Autre

2.Type d'animal touché

Other / Autre

préciser Unspecified

3. Race

Unknown

4. Nombre d'animaux touchés

1

5. Sexe:

Inconnu

6. Âge (fournir un ordre de grandeur si nécessaire)

Inconnu

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

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

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Inconnu

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Inconnu

14. b) Combien de temps l'animal était-il hospitalisé?

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

préciser No defined route of exposure was provided by the caller.

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

10/20/2022 All of the following has been spontaneously reported by the caller. Caller is reporting exposure to the product in 2015 and 2017. He would like more information about his diagnosis. He used the product 1-2 times a week as a lawn caretaker for a private customer from April 2015 through June 2015. The customer supplied a ready to use pump spray bottle. He pumped the bottle and applied the product in sweeping side to side motion on the patio. On one occasion, (date unknown) the wind blew the product on his face during application. It got into his pores, nostrils, mouth, and ears. He was wearing gloves (unspecified if chemical resistant) and long sleeves at the time of exposure. He finished the application, showered, and changed clothes within 5 hours of exposure. Around the end of March 2015, he developed a jittery feeling. Symptoms escalated and he developed nausea, lack of appetite, vomiting. He went to the hospital by ambulance in 2015 (date unknown). He told them about product exposure. They did unspecified blood work, a colonoscopy, and other unspecified tests. Symptoms continued. He was diagnosed with Chronic Lymphocytic Leukemia Lymphoma in 2017 and has been treated with chemotherapy, antibiotics, and other unspecified medications. He is unsure if he will need more chemo and is working with doctors on how to proceed. He started working for the customer again in August 2017 (after Chronic Lymphocytic Leukemia Lymphoma diagnosis). He applied the same product twice a week while wearing long sleeves and gloves. He states he was exposed to the odor of the product (date unknown). He was able to get fresh air after using the product and had no other exposures at any point. After one occasion of using the product in 2017 (date unknown), he was sitting on a patio bench, passed out, lost consciousness, fell to the ground, hit his head on the concrete and started bleeding. He was transported to the emergency room by ambulance.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

Incident report narrative, continued: He also has symptoms of numbness in his fingers, hernia, stomach pain, stomach cramps, dizziness, weakness, faintness, shakiness, and fluid filled lymph node knots that come and go. It is unclear when symptoms started. Caller stated the customers pet died also from the herbicide; however no other information was obtained before consumer disconnected. Caller does not remember exact dates and does not have product label available at the time of call. He remembers the product label saying RoundUp Herbicide. Product identified by name only. Company causality score: 0 (unlikely relationship). As the reporter did not identify a specific product alleged to have caused the exposure, Bayer has chosen to report this exposure using the selected product in this report using the information it had available, including reported use and market share. This selection may not be accurate due to the lack of information provided by the reporter. No further details were provided in this case regarding the death of a pet at the home where the product was applied. Evaluation is difficult without knowing which specific product was used, the signalment of the affected animal, the timeline of events, and circumstances of a potential exposure. In general, RoundUp products tend to have a wide margin of safety in animals under normal use conditions and small exposures to properly diluted products would not be expected to cause severe signs or death.