Nouvelle déclaration d'incident
No de la demande: 2017-4038
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0013312
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: OKLAHOMA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Large Dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Golden Retriever
1
Homme
8
28.123
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 01-Nov-2016, an 8 year old, 62 pound, neutered, male, Retriever (Golden) canine, in unknown condition, with no known concomitant medical conditions, had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date in 2017, the dog was examined by the veterinarian and was diagnosed with an unspecified neoplasia. On 17-Feb-2017, the dog died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected. This case is closed.
Mort
N - Unlikely Diagnosed neoplasia and later reported death are 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. Death, in this case was probably due to diagnosed neoplasia. Moreover, the owner did not believe in product involvement either as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Exact time to onset is unknown, but it is seems to be long. Overall, even though no necropsy was performed considering known safety profile of the product, product relation is unlikely.