Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-5766

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3714257

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

Défaillance de l'emballage

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

11-SEP-23

5. Lieu de l'incident.

Pays: UNITED STATES

État: NEW YORK

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

28-AUG-23

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. 71995-29

Nom du produit: ROUNDUP WEED & GRASS KILLER CONCENTRATE PLUS

• Matière active
  • DIQUAT, PRESENT AS DIBROMIDE
  • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
    • 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: Unknown / Inconnu

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.

Autre

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: >64 yrs / > 64 ans

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

Système

• Système cardiovasculaire
  • Symptôme - Évanouissement

• General
  • Symptôme - Oedème

• Peau
  • Symptôme - Irritation de la peau
  • Symptôme - Lésion dermale
  • Symptôme - Autre
  • Specify - Cellulitis of the arm
  • Symptôme - Dermatite
  • Specify - Seborrheic dermatitis
  • Symptôme - Rougeurs de la peau

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?

Oui

6. b) Pendant combien de temps?

1

Day(s) / Jour(s)

7. Scénario d'exposition

Inconnu

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

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

11.Durée de l'exposition?

Unknown / Inconnu

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

>3 days <=1 wk / >3 jours <=1 sem

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.)

9/11/2023 All of the following was spontaneously reported by the patient's wife. Caller is reporting her husband's skin reaction after dermal exposure to the product. Several weeks ago, he was using the diluted product, and the pump that he used "backfired," causing product to splash back onto his arms and legs. Caller does not believe he washed the product off until he was finished with his task. About 1 week later, he noticed redness, irritation, and two raised sores with a white crust over them on his arms (left arm is worse). The sores are sensitive to the touch. They applied Cetaphil (moisturizer) to the area without improvement. 9/18/2023 Attempted callback. No answer. Left message with reason for call, and case and callback numbers. 9/18/2023 Callback from consumer. Her husband was seen at an Urgent Care on 11Sept2023 and was prescribed Cephalexin. He has been taking the antibiotic and using Neosporin but there are no changes to the arm at the time of the call. The husband was diagnosed with Cellulitis of the arm and Seborrheic Dermatitis and was advised the use the antibiotic cream and follow up with his primary care practitioner. He needed to wash with warm soapy water and then use the Neosporin as that would work as the antibiotic cream. They have not been covering the areas as directed and has not been seen or have a follow up with his primary care practitioner at this time. 9/21/2023 Attempted callback: Left a detailed message requesting a callback. Case and callback numbers provided. 9/22/2023 Callback to Consumer: She states that on 21 September while getting ready for the appointment with the family doctor, her husband passed out. She took him to the emergency room, and he was admitted and is still currently in the hospital. He was originally seen in the urgent care and was diagnosed with Cellulitis and prescribed 7 days of antibiotics, which he finished.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Incident narrative, continued: He can still feel the lesion, and there is a hole in the middle of it, it is sometimes very sensitive to touch and sometimes not. She did mention the exposure to the doctors, but they did not say much in the way of thoughts. They have run several unspecified tests on her husband, and as far as she can recall, none have come back abnormal. As of right now they do not know exactly what is going on and do not have a diagnosis. 9/27/2023 Attempted callback: Left a detailed message requesting a callback. Case and callback numbers provided. 9/29/2023 Attempted callback and spoke with caller. The family doctor put him on an antibiotic cream and not the pills. They go back in 16 days to another follow up. The lump is still there, and it now has a hole in the center. His arm is sometimes very painful. The right arm is less affected. He was in the hospital overnight. No treatments were provided, no new meds. He was given an Echocardiogram, chest x-ray, head cat scan, much blood work, and an overnight heart monitor. They were not given any info about the test results, and they were not given a diagnosis. He was told to follow up with a cardiologist. He now has to wear a 30-day heart monitor. The product was mentioned to the medical staff, but they did not seem to pay any attention. No new medications were given. Caller adds that this fall incident may not have anything to do with the product and the skin symptoms. Company correlation assessment: 0 (Unlikely relationship). While the product may produce slight irritation upon dermal contact, it would be expected immediately or soon after the exposure with abatement of symptoms upon removal/decontamination. Symptoms in the described exposure appeared delayed and worsened after removal of the product. Cellulitis and seborrheic dermatitis would not be expected.

Sous-formulaire VI : Défaillance de l'emballage

1. Type d'emballage défaillant?

Spray Bottle / Flacon pulvérisateur

2. La défaillance de l'emballage est apparue pendant?

L'utilisation du produit

3. La défaillance de l'emballage a donné lieu à :

une blessure potentielle

une exposition potentielle

4.Décrire pourquoi l'emballage a été défaillant et dans quelles circonstances, décrire notamment la blessure ou l'exposition potentielle.

9/11/2023 All of the following was spontaneously reported by the patient's wife. Caller is reporting her husband's skin reaction after dermal exposure to the product. Several weeks ago, he was using the diluted product, and the pump that he used "backfired," causing product to splash back onto his arms and legs. Caller does not believe he washed the product off until he was finished with his task. About 1 week later, he noticed redness, irritation, and two raised sores with a white crust over them on his arms (left arm is worse). The sores are sensitive to the touch. They applied Cetaphil (moisturizer) to the area without improvement. 9/18/2023 Attempted callback. No answer. Left message with reason for call, and case and callback numbers. 9/18/2023 Callback from consumer. Her husband was seen at an Urgent Care on 11Sept2023 and was prescribed Cephalexin. He has been taking the antibiotic and using Neosporin but there are no changes to the arm at the time of the call. The husband was diagnosed with Cellulitis of the arm and Seborrheic Dermatitis and was advised the use the antibiotic cream and follow up with his primary care practitioner. He needed to wash with warm soapy water and then use the Neosporin as that would work as the antibiotic cream. They have not been covering the areas as directed and has not been seen or have a follow up with his primary care practitioner at this time. 9/21/2023 Attempted callback: Left a detailed message requesting a callback. Case and callback numbers provided. 9/22/2023 Callback to Consumer: She states that on 21 September while getting ready for the appointment with the family doctor, her husband passed out. She took him to the emergency room, and he was admitted and is still currently in the hospital. He was originally seen in the urgent care and was diagnosed with Cellulitis and prescribed 7 days of antibiotics, which he finished.

À l'usage du titulaire seulement

5. Donner des renseignements additionnels ici.

Incident narrative, continued: He can still feel the lesion, and there is a hole in the middle of it, it is sometimes very sensitive to touch and sometimes not. She did mention the exposure to the doctors, but they did not say much in the way of thoughts. They have run several unspecified tests on her husband, and as far as she can recall, none have come back abnormal. As of right now they do not know exactly what is going on and do not have a diagnosis. 9/27/2023 Attempted callback: Left a detailed message requesting a callback. Case and callback numbers provided. 9/29/2023 Attempted callback and spoke with caller. The family doctor put him on an antibiotic cream and not the pills. They go back in 16 days to another follow up. The lump is still there, and it now has a hole in the center. His arm is sometimes very painful. The right arm is less affected. He was in the hospital overnight. No treatments were provided, no new meds. He was given an Echocardiogram, chest x-ray, head cat scan, much blood work, and an overnight heart monitor. They were not given any info about the test results, and they were not given a diagnosis. He was told to follow up with a cardiologist. He now has to wear a 30-day heart monitor. The product was mentioned to the medical staff, but they did not seem to pay any attention. No new medications were given. Caller adds that this fall incident may not have anything to do with the product and the skin symptoms. Company correlation assessment: 0 (Unlikely relationship). While the product may produce slight irritation upon dermal contact, it would be expected immediately or soon after the exposure with abatement of symptoms upon removal/decontamination. Symptoms in the described exposure appeared delayed and worsened after removal of the product. Cellulitis and seborrheic dermatitis would not be expected.