Nouvelle déclaration d'incident
No de la demande: 2017-4473
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0028639
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: INDIANA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar large
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Australian Shepherd Dog
1
Femme
13
Inconnu
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in Jan2017, a 13 year old, neutered, female, Australian Shepherd canine, of unknown weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around neck by the owner. On an unspecified date in Apr2017, the dog died. A necropsy was not 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 further information is expected. Case is closed.
Mort
N - Unlikely Reported 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 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. Time to onset is too long (3 months). Further the owner did not believe in product involvement either as the reason for initial call was to discuss the use of the product and not to report the death of the patient. Considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out. Thus, even though no necropsy performed, product involvement is unlikely.