Nouvelle déclaration d'incident
No de la demande: 2015-3799
Numéro de référence du titulaire d'homologation: 2015KP202
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Boulevard
Ville: Missisaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
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
Inconnu
Autre
Dog / Chien
Unknown
1
Homme
Inconnu
Inconnu
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
The dog died the next day. It is unknown if a necropsy was performed. No further information is expected. This case is closed. The reporting party originally called Bayer Animal Health to determine if the collar could be stored for a period of time before being used again not to report the death of the dog.
Mort
N - Unlikely. 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 death 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. The dog was reported to have a pre-existing condition of liver tumor, which was rather the reason of death. Unknown if necropsy was performed. Time to onset short (1 day), though, but no information provided that suggested a relation to the applied collar.. The reporting party originally called Bayer Animal Health to determine if the collar could be stored for a period of time before being used again and thus, the reporter did not assume product involvement on outcome. Considering the provided data, sufficient information exists to confirm that the product did not cause the event and product involvement was considered unlikely.