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Sécurité des produits de consommation

Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2020-0595

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2601028

Nom du titulaire (nom légal complet, aucune abbréviation): Bell Laboratories, Inc.

Adresse: 3699 Kinsman Blvd

Ville: Madison

État: WI

Pays: USA

Code postal /Zip: 53704

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.

26-JAN-20

5. Lieu de l'incident.

Pays: UNITED STATES

État: TEXAS

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

26-JAN-20

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. 12455-120-3240

Nom du produit: Tomcat Mouse Killer I

  • Matière active
    • BROMETHALIN
      • Garantie/concentration .01 %

7. b) Type de formulation.

Appât

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.

Autre

2. Renseignement démographique sur la personne affectée

Sexe: Femme

Âge: >1 <=6 yrs / > 1 < = 6 ans

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

Système

  • Oeil
    • Symptôme - Dilatation de la pupille
  • Système gastro-intestinal
    • Symptôme - Nausée
    • Symptôme - Salivation excessive
    • Symptôme - Vomit
  • General
    • Symptôme - Fièvre
  • Foie
    • Symptôme - Taux élevé d'enzymes du foie
    • Specify - Elevated AST
  • Systèmes nerveux et musculaire
    • Symptôme - Faiblesse musculaire
    • Specify - Lower extremity weakness
  • General
    • Symptôme - Laryngite
    • Symptôme - Lethargie
  • Systèmes nerveux et musculaire
    • Symptôme - Tremblements musculaires

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?

5

Day(s) / Jour(s)

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.

>2 hrs <=8 hrs / > 2 h < = 8 h

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.)

1/26/2020 Caller is an emergency medical technician treating a x year old child who was found with the product about 3 hours ago. The product was spread across the ground, but no one saw the child ingest it. The parents contacted 911 because the child developed nausea, vomiting, salivation, and dilated pupils. The child was en route to the hospital via ambulance. 1/27/2020 Call to the child's mother for follow up. The child was intubated at the hospital and tests are pending. The phone connection was poor and the call disconnected. Call to the treating facility and spoke to a nurse. The child was transferred from another facility. At the initial facility the child was very lethargic so she was intubated for airway protection. An older sibling witnessed the child ingesting a significant portion of the product. She has no known underlying health conditions. She is currently sedated and on a ventilator. She was given Rocuronium and sedation. She is moving around a bit, but not purposeful movements. She does have cough and gag reflex. Pupils are equal, reactive but sluggish, and 1 to 2 millimeters. She did have a temperature of 104.3 degrees Fahrenheit, so they put her on the arctic sun protocol to cool her down. Her temperature is now 97.8 degrees Fahrenheit. She has a nasogastric tube and is getting charcoal every 4 hours. Results of a urinalysis and Procalcitonin test were pending. No testing for brain swelling had been performed as no signs of brain welling were noted. 1/28/2020 Attempted call back to the treating facility. A message was left requesting follow up information. 1/29/2020 Call back to the treating facility for follow up. Spoke with a nurse. They performed magnetic resonance imaging last night, and had to repeat it today because they missed a certain area. The result from last night was normal, and the results from today are pending. The child is awake and alert, and is reaching for toys. They are about to extubate her. They had her on vancomycin. Her blood culture was negative and urine was pending. They are planning to stop the vancomycin today. There was no official sepsis work up. Call back to the treating facility and spoke to the nurse. The magnetic resonance imaging was unremarkable. Blood culture and urine were negative. She was extubated earlier today and is currently on room air. Temperature today has been 99 to 100 degrees Fahrenheit. She tracks, gestures, reaches for toys, and was speaking and crying after extubation. She has not been talking much as her throat may be sore after extubation. They ran a respiratory culture due to vomiting during extubation, results are pending. Her urine toxicology screen was positive for benzodiazepine. The nurse was unsure of the timing of the test, and stated she was given Versed for intubation and has been on a Versed drip. She should stay in the intensive care unit tonight with plans to move her out tomorrow. They are still thinking product is the cause. 1/30/2020 Call back to the treating facility for follow up. The patient was moved out of the intensive care unit. No fever today. She has been talking a bit more, but is still whispering. The tracheal culture preliminary gram stain results came back negative, and the culture is pending. She was started on Acetylcysteine on 1/28/2020 due to elevated liver function tests. On 1/29/2020 her aspartate aminotransferase was 103 and is 59 today. Alanine aminotransferase remained normal. Acetylcysteine will be discontinued tomorrow. She had some lower extremity weakness this morning, but later got out of bed by herself and pulled her nasogastric tube out. She is on a thick liquid diet and has a swallow test tomorrow. She is starting to eat more, responds to commands, responds with yes and no and knows everyone. Intermittent tremors were reported. 1/31/2019 The child's labs and vitals were normal and she was discharged. A follow up call was placed to the child's mother who disconnected without providing further information.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.