Nouvelle déclaration d'incident
No de la demande: 2017-4021
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0022486
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
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
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
8
31.751
kg
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Persisted until death
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in approximately Sep 2016, an 8 year old, 70 pound, canine, of unknown signalment and condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On an unspecified date in approximately Nov 2016, the dog exhibited weakness, was unable to rise and died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought, in order to prevent further strain of the relationship between the reporting party and Bayer. No further information is expected; the case is closed.
Mort
N - Unlikely Reported weakness and inability to rise are unspecific signs and may have multiple other causes. Reported death is not expected following appropriate topical product application as inconsistent with product's 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. Time to onset long. No necropsy was performed. Considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is deemed to be unlikely.