Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2014-2950

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 1396684

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.

04-JUN-14

5. Lieu de l'incident.

Pays: UNITED STATES

État: NEW YORK

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

14-MAY-14

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 (refillable resistant bait station)

• 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. - In Home / Rés. - à l'int. 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?

Oui

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

• Oeil
  • Symptôme - Sensation de brûlures aux yeux
  • Symptôme - Oeil rouge

• Système gastro-intestinal
  • Symptôme - Distension abdominale

• General
  • Symptôme - Goût altéré
  • Symptôme - Enflure
  • Symptôme - Fièvre

• Systèmes nerveux et musculaire
  • Symptôme - Difficulté d'élocution
  • Specify - Speech disorder

• General
  • Symptôme - Laryngite

• Systèmes nerveux et musculaire
  • Symptôme - Confusion
  • Symptôme - Engourdissement

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?

9

Day(s) / Jour(s)

7. Scénario d'exposition

Non 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

Autre

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

11.Durée de l'exposition?

<=15 min / <=15 min

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.)

June 4, 2014. Caller has a prior medical history consisting of hypertension and Hepatitis C prior to his alleged exposure on May 10, 2014. Caller alleges that on May 10, 2014 while he was opening a bag of the product, the air from inside of the bag was emitted and reached his face. He indicated that after this exposure to the air, he experienced what he thought was a chemical taste. He was not exposed to the actual wax block of rodenticide. Two days following this exposure, he developed facial, lip, eye and neck swelling. Caller states that sometimes his whole body swells and his abdomen becomes very hard. This may likely have something to do with his Hepatitis C. Caller also states that he has fevers at night and that he is very forgetful. Caller states that he spent 1 week in the hospital but forgot to tell his doctor of his recent use of the rodenticide. Caller states that he is still swollen. Caller states that 3 days after the original exposure, he went to an allergy specialist because he was still having the swelling and a numbness and he was given an epi-pen and antihistamine. Caller never used the epi-pen but was using the antihistamine. Caller also added in that his eyes were constantly burning and were red, so his allergy MD gave him ketotifen fumarate. Caller then started to sovaldi and ribavirin for his Hepatitis C and then he lost his voice. Caller cannot recall when he was originally diagnosed with Hepatitis C but it had been several months ago. Caller then went to the ER and they kept him in the hospital for 6-7 days, but he cannot remember why but he thinks it was because he lost his voice. Caller added that inside his head was numb and also one side of his face was numb. They ran MRIs and cat scans which came back normal. Caller's hepatologist came to the hospital and took him off of the solvaldi after 4 days of being on it. Caller states that he was discharged home with a diagnosis of a "speech problem" and his vocal cord on the left of his neck was lazy. Caller denies any diagnosis of a stroke. Follow-up on June 9, 2014. Caller went to ER, and had another MRI, this time with contrast. No problems were found. No treatments were rendered. He was admitted again for 2 days, and had CAT scan, which also showed no problems. He still has abdominal swelling, but this has improved somewhat. He continues to experience problems from his hepatitis.

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. Any relationship between the use of this product and the insidious development of the complications reported in this case is inconceivable and lacks biological plausibility. Secondly, the product use history is extremely vague and lacks any description of a known or defined point of direct exposure to physical wax rodenticide. Even had casual or incidental contact with this product occurred, such illness would be unexpected and is not consistent with the toxicological profile of this product. This patient's complications appear to be an extension of a serious Hepatitis C infection.