Nouvelle déclaration d'incident
No de la demande: 2017-4030
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2016-US0037122
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: MICHIGAN
Inconnu
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
Autre
Dog / Chien
Siberian Husky
1
Femme
11
Inconnu
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 29-Jun-2016, an approximately 11 year old, female, Siberian Husky canine, of unknown weight, reproductive status, and condition, with a concomitant medical condition of blindness, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date, in Feb2017, the canine died. It is unknown 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 reason for the initial call was to discuss lost collar replacement for another dog in the household and was not to report the death of the patient. No further information is expected. This case is closed. SLEE
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. Moreover, the reason for the initial call was to discuss lost collar replacement for another dog in the household and was not to report the death of the patient. Involved animal was in advanced age (11 years) which was likely the cause of death. Time to onset is exceptionally long (almost 8 months). Although it is unknown if necropsy was performed, considering the known product profile sufficient information exists to conclude that the product did not cause the event. Hence, a product relation is deemed to be unlikely.