Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2016-5177

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 160101089

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-JUL-16

5. Lieu de l'incident.

Pays: UNITED STATES

État: KANSAS

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

17-JUN-16

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. 2724-813-270

Nom du produit: Adams Flea and Tick Spot On for Cats Over 2.5 Lbs But Under 5 Lbs

• Matière active
  • (S)-METHOPRENE
    • Garantie/concentration 3.6 %
  • ETOFENPROX
    • Garantie/concentration 40 %

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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.

1

Unités: mL

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 June 15, 2016 the owner applied the product onto the cat for prevention.

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

Cat / Chat

3. Race

Domestic Shorthair

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

6.0

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

10.88

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

>24 hrs <=3 days / >24 h <=3 jours

11. Énumérer tous les symptômes

Système

• Peau
  • Symptôme - Perte de cheveux
  • Specify - at application site
  • Symptôme - Autre
  • Specify - Ulceration

• Système gastro-intestinal
  • Symptôme - Perte d'appétit

• General
  • Symptôme - Autre
  • Specify - Behavior Change
  • Symptôme - Lethargie

• Peau
  • Symptôme - Ictère

• Sang
  • Symptôme - Anémie

• Système gastro-intestinal
  • Symptôme - Selles sanguinolentes

• Système respiratoire
  • Symptôme - Respiration difficile

• Sang
  • Symptôme - Hypoglycémie
  • Symptôme - Hypoprotéinémie
  • Symptôme - hypoalbuminémie
  • Symptôme - Autre
  • Specify - Elevated ALT
  • Symptôme - Hyperbilirubinémie
  • Symptôme - Thrombocytopénie
  • Symptôme - Autre
  • Specify - Neutropenia
  • Symptôme - Autre
  • Specify - Lymphopenia

• 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.

Oui

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

Oui

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

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 June 17, 2016 the cat developed alopecia (at application site). On June 20, 2016 the application site developed skin ulceration. On July 4, 2016 the cat developed inappetence (wouldn't eat her food, but would eat the other cat's food), a behavior change (found her with her head laying on the water bowl), and lethargy. On July 6, 2016 the cat developed icterus and anemia. Later that day, the owner took the cat to the emergency clinic, where a chemistry profile was completed. The cat was diagnosed with hypoglycemia, hypoproteinemia, hypoalbuminemia, elevated alanine aminotransferase (ALT), hyperbilirubinemia, thrombocytopenia, neutropenia, and lymphopenia. The cat's hematocrit on June 6, 2016 was 8.2 percent volume to volume (% v/v), serum glucose was 22.0 milligrams per deciliter (mg/dL), serum albumin was 2.1 grams per deciliter (g/dL), serum bilirubin total was 4.1 mg/dL, serum total protein was 5.2 g/dL, white blood cell count was 2.88 (this is very low normal), segmented neutrophils were 1.36, lymphocytes were 1.09, blood platelets were 78,000.0 count, and partial thromboplastin time was 156.0 seconds (s). The attending emergency veterinarian gave the cat butorphanol tartrate (0.1 mL intravenously (IV)), hospitalized the cat and began oxygen, and gave dextrose (2 mL injection (inj) (50% IV diluted 1:2 with saline)). On July 7, 2016 the emergency attending veterinarian started the cat on fluid therapy, a blood transfusion, and gave enrofloxacin (25 mg inj IV diluted with 1:1 saline). A few hours later the cat was transferred to a regular veterinarian. Later that morning, the cat was transferred back to the emergency clinic. The cat received fluid therapy, symptomatic and supportive care, and was given prednisolone. The cat's prothrombin time was 16.0 s. On July 8, 2016 the emergency veterinarian gave more prednisolone (10 mg by mouth (PO)) and the cat's hematocrit measured at 19.0 % v/v (post transfusion) so the anemia had become less severe. On July 11, 2016 the owner contacted the Animal Product Safety Service (APSS) to discuss the case as the cat died on July 8, 2016. The APSS veterinarian stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs as a topical agent to treat fleas. The APSS veterinarian also stated it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian further stated dermal exposures may cause mild dermal irritation, redness, pruritus, and paresthesia at the application site within the first 24-48 hours and secondary alopecia may occur from scratching or biting at the treated areas. The APSS veterinarian additionally stated oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and some animals will hypersalivate just from the odor of the product. The APSS veterinarian furthermore stated s-methoprene is an insect growth regulator (IGR). The APSS veterinarian finally stated primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers; if ingested there could be hypersalivation and nausea. The owner stated the attending veterinarian felt the cat's red blood cells (RBCs) were being destroyed. The APSS veterinarian advised the owner that the product does not directly injury the RBCs nor is it a likely culprit to elicit an allergic response. The APSS veterinarian stated she suspected it is an unfortunate coincidence and since the cat's body had been buried a recommended necropsy is no longer an option. The APSS veterinarian recommended calling back with questions after the medical record was faxed to the APSS to review.

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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 APSS veterinarian stated the alopecia and local dermatitis is likely from the product, but the anemia, icterus, and death is not. On July 12, 2016 the APSS received the faxed medical record from the emergency clinic. On July 15, 2016 the owner called the APSS to inquire whether the APSS had received the medical records. The APSS veteriarnian confirmed that the records were received and that per the previous APSS veterinarian's assessment that the most likely cause was a sepsis. On July 18, 2016 the owner called the APSS back to state that the cat developed sepsis because of the dermatitis caused by the spot on. The APSS assistant stated she would update the APSS veterinarian. The owner declined further consult with the APSS.