Nouvelle déclaration d'incident
No de la demande: 2016-6700
Numéro de référence du titulaire d'homologation: 2016KP258
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: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Australian Shepherd
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 08-Jul-2016, the reflectors fell off the collar (product defect). On approximately 31-Jul-2016, the dog was attacked by coyotes and died. The owner removed the collar. No known necropsy was performed. Due to the sensitive nature of the communication, limited information was obtained. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a storage of the collar and not to report the death of this animal.
Mort
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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. The dog was attacked by coyotes and died. Also owner does not believe in product connection as the intent of the reporting party was just to inquire about a storage of the collar and not to report the death of this animal. Finally, considering the known product profile and long time to onset even though no necropsy was performed sufficient information exists to conclude that the product did not cause the event and product involvement considered to be unlikely.