Nouvelle déclaration d'incident
No de la demande: 2015-3864
Numéro de référence du titulaire d'homologation: 2015TH276
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Blvd
Ville: Mississauga
État: ON
Pays: Canada
Code postal /Zip: L9W 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
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
unknown
1
Homme
Inconnu
Inconnu
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date, a male, canine, of unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto (unspecified) (Flumethrin- Imidacloprid) collar placed around the neck by the owner. Approximately 2 months later, on an unknown date, the dog died. It is unknown whether or not a necropsy was performed
Mort
N - Unlikely. Death would not be expected following use of the product; even not following oral ingestion or overdose. 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. Onset time not suggestive of product involvement as obviously the collar was tolerated well for 2 months. No signs of anaphylaxis reported which would have been expected to occur in close proximity to the collar application. Signs are not consistent with pharm-tox product profile. Limited information about treated animal. Unknown, why death occured. Unknown, if a necropsy was performed. But considering the provided chronology and the product's pharmacological profile, sufficient information exists to confirm that the product did not cause the event and product involvement was ruled out.