Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2015-0823

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 140143407

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.

11-NOV-14

5. Lieu de l'incident.

Pays: UNITED STATES

État: OHIO

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

09-NOV-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)

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ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 2724-803-270

Nom du produit: Adams Flea and Tick Spray for Cats

• Matière active
  • (S)-METHOPRENE
    • Garantie/concentration .1 %
  • ETOFENPROX
    • Garantie/concentration .25 %
  • PIPERONYL BUTOXIDE
    • Garantie/concentration .75 %

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7. b) Type de formulation.

Liquide

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: 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 November 8, 2014 the owner bathed the cat with cat flea shampoo and found a few fleas on her. Later that night, the owner sprayed the cat with the Adams spray.

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 III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Cat / Chat

3. Race

Domestic Longhair

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

12.0

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

8.0

lbs

8. Voie(s) d'exposition:

Cutanée

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

• Systèmes nerveux et musculaire
  • Symptôme - Coma

• Système gastro-intestinal
  • Symptôme - Salivation

• 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 November 9, 2014 the owners found the cat in a coma (they attempted to wake her, her eyes were open, she was breathing, but unresponsive and limp) and was hypersalivating (foaming). The cat was in this condition until she died that night. On November 10, the owner took the cat's body to the veterinary clinic where they planned to cremate her. On November 11, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated if ingested, gastrointestinal (GI) upset and/or a taste reaction may occur. The APSS veterinarian further stated central nervous system (CNS) depression is possible if this is alcohol based and the pet was saturated. The APSS veterinarian finally stated that the cat's signs are more severe than would be expected with label use of the product. The APSS veterinarian stated with the cat flea shampoo that systemic effects are unlikely from insecticidal shampoos and in some cats, the stress of bathing can cause decomposition of occult diseases such as heart disease. The APSS veterinarian recommended obtaining additional information (call back with flea shampoo info and lot numbers), a necropsy (owner is going to call regular veterinarian to find out if the body is still available), and calling back with questions.

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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

On November 11, 2014 the owner called the APSS to state that the veterinary clinic still had the cat's body. The APSS veterinarian stated she would get permission for the necropsy (as the body was at room temperature for 9 hours prior to taking her to the clinic), the diagnostic team stated the necropsy was fine. Shortly after, the APSS veterinarian called the veterinary clinic to discuss submission of the body for necropsy. On November 14, 2014 the veterinary staff contacted the APSS veterinarian to discuss issues she was running into while submitting the body. On November 17, 2014 an APSS technician called the veterinary staff to discuss submission for the necropsy. On November 19, 2014 the interim necropsy results were received. The interim results revealed a morphologic diagnosis of enteric nematodiasis and stated the cause of the animal's demise cannot be concluded at this time. The interim results also stated the histopathology examination is in progress, results will follow shortly, and specimens are reserved for ancillary testing if warranted by histopathology findings. On December 1, 2014 the final necropsy results were received. The final results revealed a microscopic diagnosis of chronic interstitial nephritis, hepatopathy with hepatocellular vacuoles and pigments, and pulmonary edema. The histopathology suggests that the cause of the animal's demise is possibly, in part, contributed by underlying kidney and liver diseases. Finding in the lungs is likely a terminal change. An additional histochemical stains specific for iron/hemosiderin (Prussian blue) is conducted on slide 6. The pigments found in hepatocytes are negative for Prussian blue, suggestive of lipofuscin. The final microscopic diagnosis was hepatopathy with hepatocellular vacuoles and lipofuscinosis. On December 2, 2014 the APSS veterinarian called the attending veterinary clinic to make sure they had received a copy of the necropsy result. The attending veterinary staff requested the APSS veterinarian call the owner to discuss. On December 2, 2014 the owner returned the APSS's call to discuss the results. The APSS veterinarian discussed the results with the owner that there was no specific indication as to why the pet developed signs following the application of the product. The APSS veterinarian also stated pathology finds are likely consistent with age and unlikely to have contributed to adverse reaction to application of the agent. The APSS veterinarian recommended contacting the manufacturer for additional questions or concerns.