Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2025-0696

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 4011028

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.

11-JAN-25

5. Lieu de l'incident.

Pays: UNITED STATES

État: NEW YORK

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. 12455-56

Nom du produit: Ditrac Tracking Powder

• Matière active
  • DIPHACINONE (PRESENT IN FREE FORM OR AS SODIUM SALT)
    • Inconnu

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7. b) Type de formulation.

Poudre

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?

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 - Constipation
  • Symptôme - Diarrhée
  • Symptôme - Douleur à l'estomac

• General
  • Symptôme - Fatigue

• Système gastro-intestinal
  • Symptôme - Anorexie

• General
  • Symptôme - Douleur

• Systèmes nerveux et musculaire
  • Symptôme - Insomnie

• Sang
  • Symptôme - Coagulation anormale
  • Specify - Blood clot

• Systèmes nerveux et musculaire
  • Symptôme - Mal de tête
  • Symptôme - Faiblesse musculaire

• Sang
  • Symptôme - Anémie
  • Symptôme - Leucopénie

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

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.

Respiratoire

11.Durée de l'exposition?

>1 yr / > 1 an

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.)

1/11/2025 Caller states he experienced diarrhea, constipation, loss of appetite, weakness, fatigue, insomnia, headache, body aches, and pain in lower stomach and abdomen with long term inhalation exposure. This product was applied in the basement area of his building September 2022. The heating and air system is in the basement. There is no ventilation in the basement area for the system to pull fresh air. The heating and air conditioning system pulls the air from the basement area. The caller reported the product powder was sucked up into the heat system and dispersed through the duct work, although does not specify how he knows that or if that is just what he suspects. He reported he has been inhaling the powder since 09/2022. The heating and air conditioning system was cleaned 03/2024. The caller reported the product is still coming out of the heat register in his living room. His symptoms started after product application. The symptoms get worse during the winter months when the caller spends most of his time in his apartment. During the summer months he does not spend much time at home and symptoms improve. The caller reported his symptoms seem to be progressively worse over the last few months. The caller first saw his primary care practitioner for evaluation of symptoms approximately 10/2022. He advised his primary care practitioner of his concerns about inhaling the product at that time. He is currently still under doctor care for above listed symptoms. The caller has had blood work drawn approximately 20 times since 2022. The results have been within normal limits except a few times he had low red and white blood cells and. His doctor has completed X ray of his stomach with normal results. The last X ray was completed approximately 01/03/2025. The doctor has also ordered computed tomography scans of abdomen from lower stomach to chest all with normal results. The last computed tomography scan was completed on approximately 01/03/2025.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Narrative, continued: His doctor prescribed him medication for his sx. His doctor prescribed xifaxan 10/2024, Spironolactone 01/2025, and Lactulose 01/2025. The caller has not seen any improvements in his symptoms with use of prescribed medications. The caller reported the medications are for treatment of liver failure but he has not been diagnosed. The caller confirmed the doctor did not say he had liver failure. The doctor has not given him a diagnosis. The caller expressed his doctor has not examined his internal organs. The caller has a follow up appointment with his primary care practitioner this coming week. He has also spoken with NY State [Department]. 1/16/2025 Attempted callback. Call was answered and disconnected. Attempted callback and spoke with caller. He states he is the same if not worse. He reports he has test results that state what the powder is. 1/23/2025 Attempted callback. No answer. Full mailbox. Unable to leave message. /24/2025 Caller states that whenever he returns to his home his symptoms return. He states he is staying with a friend, and he returned home about 2 weeks ago, and his symptoms returned. He went to the emergency room, and they admitted him to the hospital. The emergency room doctors were concerned with his heart and the old blood clot that they saw on heart scan. They gave him new heart failure medication and will need to follow up with cardiologist. His liver function was normal if they are telling him the truth. He was discharged after 5 days. He states his symptoms persist. He saw a gastroenterologist 01/23/2025 and they drew blood for kidneys and liver he was given Lactose for constipation and liver. No results back on kidney and liver function. He stated he took his first dose of Lactose yesterday and he was feeling better. He has a follow up appointment with gastroenterologist the first week in February 2025. No further information is available. 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.