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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: 2016-1427

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 150147846

Nom du titulaire (nom légal complet, aucune abbréviation): Wellmark International

Adresse: 100 Stone Road West, Suite 111

Ville: Guelph

État: Ontario

Pays: Canada

Code postal /Zip: N1G5L3

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Incident chez un animal domestique

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

25-OCT-15

5. Lieu de l'incident.

Pays: UNITED STATES

État: FLORIDA

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

25-OCT-15

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. 1021-2684-89459

Nom du produit: Adams Flea And Tick Dip For Dogs And Cats

  • Matière active
    • PIPERONYL BUTOXIDE
      • Garantie/concentration 3 %
    • PYRETHRINS
      • Garantie/concentration .3 %

7. b) Type de formulation.

Liquide

Renseignments sur l'application

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

Oui

9. Dose d'application.

4

Unités: oz (fl) / oz (liquide)

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

Site: Animal / Usage sur un animal domestique

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

On October 25, 2015 the owner used the product on the dog (diluted 4 ounces (oz) in 1 gallon of water per label).

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 III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Cocker Spaniel

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

6. Âge (fournir un ordre de grandeur si nécessaire)

7.0

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

<=15 min / <=15 min

10. Temps écoulé entre l'exposition et l'apparition des symptômes

<=30 min / <=30 min

11. Énumérer tous les symptômes

Système

  • Systèmes nerveux et musculaire
    • Symptôme - Collapsus
  • 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?

Treatment / Traitement

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

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

On October 25, 2015 the dog collapsed, so the owner bathed the dog (using Dawn). Shortly after the dog died. Later that evening, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian provided information that death is not expected, so more answers would be needed. The APSS veterinarian recommended a necropsy, having the veterinarian call for information, and calling back with questions.


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 APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On October 26, 2015 the owner called back to discuss payment for the necropsy and her concerns for sending the dog's body out. The APSS assistant recommended the attending veterinarian call the APSS to discuss the details. On October 26, 2015 the attending veterinary technician called the APSS to discuss the necropsy. Later that morning the owner called the APSS to request a copy of the necropsy findings. Shortly after the attending veterinarian called the APSS to state that she did convince the owner to submit the whole body and questioned what type of necropsy would be done. The APSS veterinarian stated that the gross necropsy findings would be sent to the APSS and to the clinic and the histo results usually take a few weeks to receive. On October 29, 2015 the APSS received the interim report. The morphologic diagnosis showed the body as a whole showed icterus and anemia; the skin showed ectoparasitism (marked flea infestation), hyperkeratosis (multifocal), and claw (overgrowth); the spleen showed splenic nodules; the testis showed testicular tumor (left and right); the prostrate showed moderate prostatomegaly; and the bone marrow was reactive. On November 5, 2015 the final necropsy results were received. The brain showed intracytoplasmic eosinophil inclusion bodies and neuronal cell bodies; the liver showed centrilobular necrosis; the liver showed portal bridging fibrosis; the liver showed vacuolar hepatopathy; the bone marrow showed myeloid and erythroid hyperplasia; the spleen showed extramedullary hematopoiesis; the kidney showed renal tubular proteinosis and hypertrophy; the lungs showed smooth muscle hypertrophy and anthracosis; the testis showed sertoli cell turmor; and the skin showed hepatoid gland hypertrophy. Postmortem findings are supportive of this animal being anemic as not a large amount of blood was observed at necropsy examination. Histologically there is centrilobular hepatic necrosis consistent with hypoxia/anemia, extramedullary hematopoiesis within the spleen and reactive diaphyseal bone marrow. Large numbers of fleas are identified on this dog which would explain the suspected anemia. This dog has gross evidence of icterus and testing for infectious agents such as Anaplasma spp. and Ehrlichia spp. can be performed for an additional fee. The severe anemia is considered to have most likely caused the death of this animal. Numerous inclusion bodes are identified with neuronal cell bodies and Purkinje cells within the brain. Immunohistchemical staining of the brain for rabies virus and canine distemper virus are negative. The inclusions are consistent with Rabies-like inclusion bodies. Within the kidneys there is hypertrophy of the epithelium lining distal convoluted tubules. A cause for this is not known. No further tests are pending. The APSS veterinarian stated that anemia was considered to have a high likelihood of causing the clinical situation. On November 7, 2015 the APSS veterinarian made an attempt to call the owner to discuss the necropsy results. On November 9, 2015 the APSS veterinarian called the attending veterinary clinic to discuss the necropsy results. The attending veterinarian stated they had received the results and did not have further questions. Shortly after the APSS veterinarian called the owner to discuss the necropsy results and left a message stating her veterinary clinic had a copy of the results and how to reach the APSS if she had any questions.