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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: 2017-4925

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0041300

Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc

Adresse: 2920 Matheson Blvd

Ville: Mississaugua

État: ON

Pays: Canada

Code postal /Zip: L4W 5R6

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.

10-JUL-17

5. Lieu de l'incident.

Pays: UNITED STATES

État: FLORIDA

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

09-JUL-17

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. 11556-155

Nom du produit: Seresto Cat Collar

  • Matière active
    • FLUMETHRIN
    • IMIDACLOPRID
      • Garantie/concentration 10 %

7. b) Type de formulation.

Autre (préciser)

Collar

Renseignments sur l'application

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

Oui

9. Dose d'application.

1

Autres unités: collar

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.)

A 2 year old, 8 pound, neutered, male, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner.

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

Professionnel de la santé

2.Type d'animal touché

Cat / Chat

3. Race

Domestic Shorthair

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

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

2

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

3.629

kg

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

>1 mo <= 6 mos / > 1 mois < = 6 mois

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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. Énumérer tous les symptômes

Système

  • Peau
    • Symptôme - Lésion dermale
  • Sang
    • Symptôme - Thrombocytopénie
  • Système respiratoire
    • Symptôme - Dyspnée
  • Systèmes nerveux et musculaire
    • Symptôme - Allongé
  • Système gastro-intestinal
    • Symptôme - Salivation excessive
  • General
    • Symptôme - Hémorrhagie internale
    • Symptôme - Oedème
    • Symptôme - Mort

12. Quelle a été la durée des symptômes?

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

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 10-Mar-2017, a 2 year old, 8 pound, neutered, male, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 09-Jul-2017, the cat was found with the collar in his mouth; the collar was removed. The cat was examined by an emergency veterinarian and was laterally recumbent, dsypnic and had lesions present in the corners of the mouth. Bloodwork was performed and revealed thrombocytopenia. The cat was treated with supplemental oxygen. On 10-Jul-2017, the cat was seen by the attending veterinarian; all clinical signs continued. A lateral chest radiograph did not reveal any sufficient finding. No other treatments were performed. Follow up received on 17th Jul 2017: On 10-Mar-2017, a 2 year old, 8 pound, neutered, male, Domestic Shorthair feline, in fair condition, with concomitant medical conditions of eyelid agenesis, blind in right eye and fleas, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 09-Jul-2017, the cat was found with the collar in his mouth; the collar was removed. The cat was hypersalivating, was hemorrhaging from his paws, had facial edema and dyspnea. The cat was examined by an emergency veterinarian and was laterally recumbent, dsypnic and had lesions present in the corners of the mouth. Bloodwork was performed and revealed thrombocytopenia. The cat was treated with supplemental oxygen, intraveneous fluids and an unspecified antibiotic. On 10-Jul-2017, the cat was seen by the attending veterinarian; all clinical signs continued. A lateral chest radiograph did not reveal any sufficient finding. The cat recieved a steroid injection and an unknown medication. The cat was transferred to the emergency clinic for observation through the night. On 11-Jul-2017, the cat passed away. No necropsy was performed. No more information is expected. Case is closed.


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

O - Unclassifiable/unassessable Cat was found with the collar in mouth. Reported lesions present in the corners of the mouth are related to the inappropriate collar position.Although not clearly stated, it is possible that collar application was too loose enabling the pet to move the collar in the inappropriate position. Other signs of hypersalivating may be related to the collar position as well, however hemorrhaging paws, facial edema and dyspnea and later reported recumbency are not expected with the described collar position. Signs may be secondary to the cat having the collar in the mouth and related to cat's agitation and the attempts to remove the collar. However ongoing signs despite collar removal are untypical and rather suggest other underlying conditions. Concurrently diagnosed thrombocytopenia is not expected as inconsistent with pharmaco-toxicological product profile. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Time to onset is consistent for signs associated with collar trapping but it is long for later diagnosed thrombocytopenia and death. No necropsy not performed. Other unrelated causes must be consider in this case. Overall, a product relation is unassessable.