Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2018-6632

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2309573

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

Incident chez un animal domestique

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

18-SEP-18

5. Lieu de l'incident.

Pays: UNITED STATES

État: TEXAS

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

Inconnu

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. 12455-95

Nom du produit: Fastrac All-Weather Blox

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

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7. b) Type de formulation.

Appât

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.

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

• Système gastro-intestinal
  • Symptôme - Distension abdominale
  • Symptôme - Gonflement
  • Symptôme - Constipation
  • Symptôme - Autre
  • Specify - Colon pain
  • Symptôme - Autre
  • Specify - Weight gain

• Sang
  • Symptôme - Leucoytose
  • Symptôme - Hyperglycémie
  • Symptôme - Autre
  • Specify - Eosinophilia
  • Symptôme - Autre
  • Specify - Monocytosis
  • Symptôme - Autre
  • Specify - Hemoglobin A1C increased

• Système gastro-intestinal
  • Symptôme - Douleur à l'estomac

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?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

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

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)

Inconnu

10. Voie(s) d'exposition.

Inconnu

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.)

9/18/2018 12:00:10 PM The reporter purchased two packages of product approximately one year ago. He has been handling the containers with his hands though had no direct contact with the product that he is aware of. He was trying to determine the cause of his own symptoms and those experienced by his mother as their doctors have not been able to. He had brought a container of product to his mother's house and he believes she used some of the packs, though no specific exposure to the product is known. He also mentioned that his mother's two dogs died one week apart within the past eight weeks. Both dogs died at home in the back yard. No diagnostics were performed on them in order to determine a cause of death. The reporter did not have any other information about the dogs and declined discussing them further. The reporter has been experiencing colon pain, constipation, bloating, abdominal pain, and weight gain all of which have worsened over the past 18 months. He was evaluated by a doctor several times and diagnostics including a CT scan and a colonoscopy, both of with unremarkable results. Blood tests showed elevated A1C (6.4 with normal less than 5.7, mild eosinophilia (738 with normal up to 500), mild monocytosis (1202 with normal up to 950), mild leukocytosis (11.9 with normal up to 10.8), and mild hyperglycemia (114 with high normal 99). He was also evaluated by an oncologist who stated that his signs were due to smoking and his blood being too thick. The reporter's mother was previously hospitalized for two weeks (dates unknown) with symptoms including hallucinations, shaking as if she was having a seizure, and she also had a stroke. She was admitted again two weeks prior and still hospitalized at the time of the call. Her symptoms included abdominal pain and distention, vomiting, constipation, and a low-grade fever. She was treated with IV fluids, antibiotics, heparin, and had two blood transfusions. Diagnostics included a CT scan, endoscopy, and colonoscopy but the doctors have not provided a diagnosis. A bone marrow test was also performed but results were not available at the time. During a follow-up call on 9/28/2018 the reporter stated his mother was discharged from the hospital that day. The doctors did not have an opinion as to whether the product was a cause of her symptoms.

À être déterminé par le titulaire

14. Classification selon la gravité.

Modérée

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.

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: Femme

Âge: >64 yrs / > 64 ans

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

Système

• Système gastro-intestinal
  • Symptôme - Distension abdominale
  • Symptôme - Constipation
  • Symptôme - Douleur à l'estomac
  • Symptôme - Vomit

• General
  • Symptôme - Fièvre

• Systèmes nerveux et musculaire
  • Symptôme - Hallucination
  • Specify - Hallucinations/Delusion
  • Symptôme - Agitation

• Système cardiovasculaire
  • Symptôme - Accident cérébrovasculaire

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?

3

Week(s) / Semaine(s)

7. Scénario d'exposition

Non professionnel

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

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)

Inconnu

10. Voie(s) d'exposition.

Inconnu

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.)

9/18/2018 12:00:10 PM The reporter purchased two packages of product approximately one year ago. He has been handling the containers with his hands though had no direct contact with the product that he is aware of. He was trying to determine the cause of his own symptoms and those experienced by his mother as their doctors have not been able to. He had brought a container of product to his mother's house and he believes she used some of the packs, though no specific exposure to the product is known. He also mentioned that his mother's two dogs died one week apart within the past eight weeks. Both dogs died at home in the back yard. No diagnostics were performed on them in order to determine a cause of death. The reporter did not have any other information about the dogs and declined discussing them further. The reporter has been experiencing colon pain, constipation, bloating, abdominal pain, and weight gain all of which have worsened over the past 18 months. He was evaluated by a doctor several times and diagnostics including a CT scan and a colonoscopy, both of with unremarkable results. Blood tests showed elevated A1C (6.4 with normal less than 5.7, mild eosinophilia (738 with normal up to 500), mild monocytosis (1202 with normal up to 950), mild leukocytosis (11.9 with normal up to 10.8), and mild hyperglycemia (114 with high normal 99). He was also evaluated by an oncologist who stated that his signs were due to smoking and his blood being too thick. The reporter's mother was previously hospitalized for two weeks (dates unknown) with symptoms including hallucinations, shaking as if she was having a seizure, and she also had a stroke. She was admitted again two weeks prior and still hospitalized at the time of the call. Her symptoms included abdominal pain and distention, vomiting, constipation, and a low-grade fever. She was treated with IV fluids, antibiotics, heparin, and had two blood transfusions. Diagnostics included a CT scan, endoscopy, and colonoscopy but the doctors have not provided a diagnosis. A bone marrow test was also performed but results were not available at the time. During a follow-up call on 9/28/2018 the reporter stated his mother was discharged from the hospital that day. The doctors did not have an opinion as to whether the product was a cause of her symptoms.

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.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Unknown

4. Nombre d'animaux touchés

2

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:

Inconnu

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.

Non

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Non

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?

Other / Autre

préciser Unknown exposure to pesticide

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

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

9/18/2018 12:00:10 PM The reporter purchased two packages of product approximately one year ago. He has been handling the containers with his hands though had no direct contact with the product that he is aware of. He was trying to determine the cause of his own symptoms and those experienced by his mother as their doctors have not been able to. He had brought a container of product to his mother's house and he believes she used some of the packs, though no specific exposure to the product is known. He also mentioned that his mother's two dogs died one week apart within the past eight weeks. Both dogs died at home in the back yard. No diagnostics were performed on them in order to determine a cause of death. The reporter did not have any other information about the dogs and declined discussing them further. The reporter has been experiencing colon pain, constipation, bloating, abdominal pain, and weight gain all of which have worsened over the past 18 months. He was evaluated by a doctor several times and diagnostics including a CT scan and a colonoscopy, both of with unremarkable results. Blood tests showed elevated A1C (6.4 with normal less than 5.7, mild eosinophilia (738 with normal up to 500), mild monocytosis (1202 with normal up to 950), mild leukocytosis (11.9 with normal up to 10.8), and mild hyperglycemia (114 with high normal 99). He was also evaluated by an oncologist who stated that his signs were due to smoking and his blood being too thick. The reporter's mother was previously hospitalized for two weeks (dates unknown) with symptoms including hallucinations, shaking as if she was having a seizure, and she also had a stroke. She was admitted again two weeks prior and still hospitalized at the time of the call. Her symptoms included abdominal pain and distention, vomiting, constipation, and a low-grade fever. She was treated with IV fluids, antibiotics, heparin, and had two blood transfusions. Diagnostics included a CT scan, endoscopy, and colonoscopy but the doctors have not provided a diagnosis. A bone marrow test was also performed but results were not available at the time. During a follow-up call on 9/28/2018 the reporter stated his mother was discharged from the hospital that day. The doctors did not have an opinion as to whether the product was a cause of her symptoms.

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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

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.