Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-5623

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3698255

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.

24-AUG-23

5. Lieu de l'incident.

Pays: UNITED STATES

État: INDIANA

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

27-JUL-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 34095      ARLA No de la demande d'homologation       EPA No d'homologation. 264-1207

Nom du produit: Delaro Complete

• Matière active
  • FLUOPYRAM
  • PROTHIOCONAZOLE
    • Inconnu
  • TRIFLOXYSTROBIN (CGA 279202)
    • 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: Agricultural-Outdoor/Agricole-extérieur

Specify Type: Field

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: >19 <=64 yrs / >19 <=64 ans

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

Système

• General
  • Symptôme - Goût de métal dans la bouche

• Système gastro-intestinal
  • Symptôme - Avoir des haut-le-coeur

• General
  • Symptôme - Diaphorèse
  • Symptôme - Faiblesse

• Systèmes nerveux et musculaire
  • Symptôme - Mal de tête
  • Symptôme - Autre
  • Specify - Feeling total body paralysis

• General
  • Symptôme - Sensation de faiblesse

• Systèmes nerveux et musculaire
  • Symptôme - Autre
  • Specify - Seizure-like activity
  • Symptôme - Autre
  • Specify - Stroke-like symptoms

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?

2

Day(s) / Jour(s)

7. Scénario d'exposition

Non professionnel

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

Contact avec la zone traitée

Quelle était l'activité? Walked through his barn and the treated field, and touched his livestock which were sprayed.

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

Orale

Respiratoire

11.Durée de l'exposition?

Unknown / Inconnu

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

>24 hrs <=3 days / >24 h <=3 jours

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.)

8/24/2023 Consumer calling to report stroke like symptoms, seizure like activity, metallic taste, sweating, headaches, weakness, severe light headedness, dry heaving, and feeling total body paralysis after possible exposure to Delaro complete. Caller reports that on 7/27, there was a plane that passed over his barn and fields about three times spraying this product (however it was intended to have been sprayed on the fields of the neighboring farm). Consumer stated he was not directly sprayed, however he did go out to the barn shortly after this and he said he could smell the product and sort of taste the product when he went out into the field. He stated the barn is relatively open and that he thinks some of the spray did get into the barn, and was also sprayed directly onto some of his livestock. Consumer stated that he went out into the field and handled his livestock shortly after the exposure, so a dermal exposure could be possible. Consumer stated that a couple of days after the possible exposure, around 7/30, he developed severe headaches, weakness, and a metallic taste in his mouth. He state that he tried ibuprofen and acetaminophen to treat headaches but this didn't help. He stated the metallic taste is still ongoing and is intermittent. He stated that on 8/12 was in the barn cleaning and started profusely sweating. He stated he went to get some water and became severely lightheaded, was dry heaving, and he said he barely made it to the house where he then sat on the porch swing. He reports developing a severe headache after 15 minutes of sitting, at which point ems was called. He stated he had total body paralysis and seizure like activity before emergency medical services arrived. He reports it was not overly hot that day, he thinks it was in the low 80s and he was in and out of the barn working prior to the event. Consumer stated he was admitted to the hospital 8/12, was discharged late on 8/14.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Incident narrative, continued: Consumer stated he was diagnosed with stroke like symptoms and seizure like activity but no definitive cause was identified by the doctors. He said during his hospitalization he had an intravenous catheter placed, but could not recall what treatments were given to him. He did state that he had an electroencephalogram that was abnormal and that he was discharged with a seizure medication to take as needed but he has not needed to take any. He reports he has an appointment with his family doctor today and is scheduled to have a 48-hour electroencephalogram next month. He said he did tell the doctors near the end of his hospitalization that he had been exposed to something on July 27th but he didn't have the specific information on what the product was. He said the doctors did not mention anything about this exposure being the cause of his symptoms. Caller also reports one of his herd of cattle died post exposure, and the rest had unspecified symptoms. 8/24/2023 Left message with consumer to callback to follow up with cattle symptoms and details of exposure. 8/25/2023 Attempted callback to follow up with cattle symptoms and details of exposure. Left voice message for with reason for calling, asked caller to contact us at provided number and reference case number to provide information. Company correlation assessment: 1 (Unlikely relationship). No known direct exposure occurred to the product. If he was exposed dermally to the product while working with the livestock it was not a noticeable amount. Symptoms did not occur until three days after application of the product. The symptoms reported are not expected given the ingredients in the product, the described exposure and the onset of symptoms three days later. All other differential diagnoses have not been ruled out and symptoms have not improved upon removal from the product.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Cow / Vache

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:

Cutanée

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?

Spray drift / Dérive de pulvérisation

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

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

8/24/2023 Consumer calling to report stroke like symptoms, seizure like activity, metallic taste, sweating, headaches, weakness, severe lightheadedness, dry heaving, and feeling total body paralysis after possible exposure to Delaro complete. Caller reports that on 7/27 there was a plane that passed over his barn and fields about three times spraying this product (however it was intended to have been sprayed on the fields of the neighboring farm). Consumer stated he was not directly sprayed, however he did go out to the barn shortly after this and he said he could smell the product and sort of taste the product when he went out into the field. He stated the barn is relatively open and that he thinks some of the spray did get into the barn, and was also sprayed directly onto some of his livestock. Consumer stated that he went out into the field and handled his livestock shortly after the exposure, so a dermal exposure could be possible. Consumer stated that a couple of days after the possible exposure, around 7/30, he developed severe headaches, weakness, and a metallic taste in his mouth. He state that he tried ibuprofen and acetaminophen to treat headaches but this didn't help. He stated the metallic taste is still ongoing and is intermittent. He stated that on 8/12 was in the barn cleaning and started profusely sweating. He stated he went to get some water and became severely lightheaded, was dry heaving, and he said he barely made it to the house where he then sat on the porch swing. He reports developing a severe headache after 15 minutes of sitting, at which point ems was called. He stated he had total body paralysis and seizure like activity before emergency medical services arrived. He reports it was not overly hot that day, he thinks it was in the low 80s and he was in and out of the barn working prior to the event. Consumer stated he was admitted to the hospital 8/12, was discharged late on 8/14.

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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 narrative, continued: Caller also reported one of his herd of cattle died post exposure, and the rest had unspecified symptoms. 8/24/2023 Left message with consumer to callback to follow up with cattle symptoms and details of exposure. 8/25/2023 Attempted callback to follow up with cattle symptoms and details of exposure. Left voice message for with reason for calling, asked caller to contact us at provided number and reference case number to provide information. Company correlation assessment: 0 (Unlikely relationship). Very limited information was provided in this case regarding the deaths of some of the cows on this farm. It was not specified how long after exposure the cows died or if any clinical signs were observed prior to death. However, the three fungicidal active ingredients in the product are all considered to have a low order of toxicity in mammals. Significant clinical signs are not expected following acute exposure.