Imprimer | Besoin d'un texte plus grand?

Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-5765

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3702737

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.

5. Lieu de l'incident.

Pays: UNITED STATES

État: CONNECTICUT

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

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.

ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 71995-49

Nom du produit: ROUNDUP CONCENTRATE MAX CONTROL 365

• Matière active
  • DIQUAT
    • Inconnu
  • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
    • Inconnu

7. b) Type de formulation.

Liquide

Renseignments sur l'application

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

Non

9. Dose d'application.

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

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

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.

Professionnel de la santé

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

• Système respiratoire
  • Symptôme - Syndrome de détresse respiratoire aiguë

• General
  • Symptôme - Autre
  • Specify - Multi organ failure

• Systèmes nerveux et musculaire
  • Symptôme - Autre
  • Specify - No neurological activity

• Système rénal
  • Symptôme - Insuffisance rénale

• Système gastro-intestinal
  • Symptôme - Autre
  • Specify - Esophageal burning
  • Symptôme - Nausée
  • Symptôme - Vomit

• Système respiratoire
  • Symptôme - Fonction pulmonaire diminuée

• General
  • Symptôme - Autre
  • Specify - Organ toxicity

• Système respiratoire
  • Symptôme - Autre
  • Specify - Lungs a complete whiteout on chest x-ray

• Système rénal
  • Symptôme - Anurie

• Systèmes nerveux et musculaire
  • Symptôme - Autre
  • Specify - No cough reflex
  • Symptôme - Autre
  • Specify - No gag reflex
  • Symptôme - Autre
  • Specify - No pain response

• Oeil
  • Symptôme - Diminution du réflexe pupillaire

• Système rénal
  • Symptôme - Augmentation du taux de créatinine

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?

Inconnu

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

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)

Aucun

10. Voie(s) d'exposition.

Orale

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.)

8/29/2023 The caller is inquiring about where to have the patient's levels checked, if there is one, for Glyphosate and Diquat. Caller reports the following: He is a pharmacist at toxicology department at the hospital, on the team treating the patient. On 24Aug2023 at 7am local time, the patient intentionally ingested 16oz of the product with also having Melatonin and Valproic acid in his system. The patient was initially seen in another hospital before being transferred to the current hospital. Little information about the symptoms that the patient experienced but the patient is on multiple life support measures including extracorporeal membrane oxygenation and continuous veno-venous hemofiltration and sedation for a day and is showing no signs of neurological activity, multi organ failure including profound renal failure and acute respiratory distresses syndrome leading to lung functions going down. They did not get exact product information until last night, 28Aug2023 which confirmed that Diquat is in the product consumed. 8/31/2023 Callback attempted to the initial caller. Left message on voice mail with case number and callback information. 9/1/2023 Listened to the original call recording. Caller also reported the following: Valproic Acid, level known but not provided, and Melatonin were also reported as ingestants. RoundUp was the "primary ingestion." They initially thought it was just glyphosate in the product but when the patient developed renal failure, acute respiratory distress syndrome and decreased lung function they suspected diquat. They were able to confirm the product the previous night before the call and confirmed both glyphosate and diquat were in the product. They did not specify reason for wanting the levels. 9/1/2023 Callback to hospital pharmacist to follow up on patient status.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Incident narrative, continued: . He reports the following: The patient initially drove himself and presented ambulatory, alert and oriented to a smaller hospital ER sometime on August 24, 2023 with complaints of esophageal burning, nausea and vomiting. Patient said he drank a RoundUp product in addition to Valproic Acid and Melatonin over the prescribed amount, but the pharmacist does not recall any specific amounts being reported. He was transferred to their larger hospital August 25th or early am August 26, 2023 with the first ICU notes dated early am August 26, 2023. They were told by the smaller hospital that the product ingested was RoundUp, and they were initially only considering it to be a glyphosate exposure and treating supportively. However, with the way the patient's condition rapidly declined they began to suspect an exposure to Diquat, and this is when they started looking for ways to do serum testing to confirm what the ingestion was and determine if it was a diquat and glyphosate exposure. They understood this would not change the course of symptomatic and supportive care, but the reasoning to pursue levels was more from an academic interest standpoint as a possible case report as this type of ingestion is so rare in their experience. The patient's Valproic Acid levels peaked at 200 after approximately 2 days, and then gradually decreased to therapeutic levels. They generally do not get concerned about Valproic Acid levels until they reach 500. They did not test for Melatonin since in their experience, even large ingestions have not been cause for toxicity concern or require treatment. Over the first 24-48 hours after admission to their hospital, the patient remained alert and oriented though his creatinine levels were increasing and kidney function was declining, then he rapidly declined with signs of organ toxicity (no specific lab test results known). The initial chest xray done August 25, 2023 looked normal, but 2 days later on repeat chest xray, the caller states the pulmonologist verbally referred to the patient's lungs: "are a complete whiteout". with the Xray image of the lung fields a white color where you would usually see black. They were later informed by the initial hospital that the product was confirmed as they had the empty bottle of ROUNDUP CONCENTRATE MAX CONTROL 365 identified by the EPA number which was found in the patient's car that he drove to the ER in and stated that the pt poured 16 oz of this undiluted product into a type of drinking bottle and drank it. (ER also has that bottle). Patient's status is known up to yesterday to the pharmacist. Patient has had no urine output for the last 5 days as of yesterday. He remains on life support with minimal neurological response for the past few days, and no cough or gag reflex. There had also been no pain response and his pupils had been unresponsive to light. In a chart note update yesterday it was noted that the patient's pupils showed some response to light, and he appeared to withdraw to pain. Their hospital team contacted NMS Labs to pursue serum testing since the initial hospital drew lab work within 2 hours of the ingestion and these samples are still available for testing. They were informed by the lab that the samples needed to have been stored in an opaque container away from light to be tested. The samples available were not collected or stored in opaque containers and have been stored in the fridge. The pharmacist would still be interested in pursuing serum testing if there are any other known resources or options to utilize the samples they do have from an academic interest standpoint. 9/7/2023 Follow up call to hospital pharmacist attempted. Left message on voicemail requesting return call with case number and callback number. 9/12/2023 Follow up call to hospital pharmacist attempted. Left message on voicemail requesting return call with case number and callback number.