Nouvelle déclaration d'incident
No de la demande: 2017-4924
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0040927
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: MISSOURI
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
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Homme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in approximately 2016, a male, canine, of unknown age, weight, breed and condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date post application, in approximately 2016, the dog 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. The reason for the initial call to Bayer Animal Health was to discuss Seresto on his other dog and not to report the death of the patient. No further information is expected. This case is closed.
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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, the intent of calling was to discuss the product use on his other dog and not to report the death of the patient. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (almost after 6 months). Even though some information is not available (e.g time to onset and necropsy report), considering the known product profile and other aspects, a product relation is unlikely.