Nouvelle déclaration d'incident
No de la demande: 2017-6513
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0049386
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
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 unknown
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Crossbred (Dog)
1
Homme
8
Inconnu
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Other / Autre
préciser Unknown
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in Aug 2016, a 8 year old, of unknown weight, male, Dachshund/Beagle crossbred canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog Collar (unspecified) (Flumethrin-Imidacloprid) placed around the neck by the owner. On an unspecified date in Apr2017 the dog died from unspecified causes. It is unknown if the dog was examined by a veterinarian or if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The initial communication from the reporting party was to inquire about using the Seresto collar on a new pet and not to report this event. No further information is expected. This case is closed.
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 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. Moreover, the intent of the call was to discuss product use on another pet and not to report the death of the dog. Time to onset is long. Other unrelated causes are more probable. Even though some information is not available (e.g. health status and necropsy report), considering known safety profile of the product a product relation is unlikely.