Nouvelle déclaration d'incident
No de la demande: 2017-6542
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0037442
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 large
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 01-Jun-2017, a dog of unknown signalment, in unknown condition, with no known concomitant medical conditions, had one Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On approximately 22Jun2017, the dog died and no necropsy was performed. The reason for the initial call was to discuss whether the collar could now be used on a smaller dog in the home and not to report the death in this event. Specific, relevant event details were not obtained, nor will such be sought. No further information is expected. This 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 sign 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. Further the owner did not believe in product involvement either as the reason for the initial call was to discuss whether the collar could now be used on a smaller dog in the home and not to report the death in this event. Time to onset is long. Even though, no information available (animal details, health condition, medical history and necropsy results), considering known safety profile of the product, a product relation is unlikely.