Nouvelle déclaration d'incident
No de la demande: 2017-6539
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0037051
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
Incident chez un animal domestique
Pays: UNITED STATES
État: NORTH CAROLINA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar small cat
Autre (préciser)
collraOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Homme
16
2.722
kg
Cutanée
>3 days <=1 wk / >3 jours <=1 sem
>3 days <=1 wk / >3 jours <=1 sem
Système
Persisted until death
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 19-Jun-2017, a 16 year old, 6 pound, neutered, male, Domestic Shorthair feline, in unknown condition, concomitant medical conditions of generalized alopecia and fleas, had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On 23Jun2017, the cat exhibited application site alopecia, application site erythema, lethargy, a decreased appetite, and not drinking. On 26Jun2017, the owner removed the collar, the cat was examined by a veterinarian, it was unknown if treatments or tests were performed, and the cat died. No necropsy was performed. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable The reported application site disorders may occur in sensitive animals after product application. They are usually mild and transient. Additionally reported systemic signs are unspecific and may have numerous other causes. Signs may occur initially after collar administration. However death is not expected following appropriate topical product application as it is inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious 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. However, in this case the animal is a geriatric patient and other underlying health problems cannot be ruled out. Moreover, information on treatments, tests and necropsy are unavailable. Even though time to onset is short for the reported application site and systemic signs, it is definitely long for the serious systemic sign of death. Considering overall information in this case, product relation was considered unassessable.