Nouvelle déclaration d'incident
No de la demande: 2017-4913
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0039514
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 Large Dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Pit Bull /Siberian Husky crossbred
1
Homme
Inconnu
20.412
kg
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 Sep2016, a 45 pound, male, Pit Bull /Siberian Husky crossbred canine, of unknown age, in unknown condition, with concomitant medical conditions of fleas, and hair loss, had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. Approximately 24 hours post application, on an unknown date in Sep2016, the fleas resolved. Approximately 2 weeks post application, in 2016, the hair loss resolved. On an unspecified date in Apr2017, the canine exhibited weight loss and died. It was 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 use of the product not to report the death in this event. No Further information is expected case is closed.
Mort
N - Unlikely Reported weight loss and death are 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 like death 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 is too long. Further, the owner did not believe in product involvement either as the reason for the initial call was to discuss use of the product not to report the death in this event. Considering these aspects, in spite of the limited information (necropsy results and medical history), considering known safety profile of the product, product relation is unlikely.