Nouvelle déclaration d'incident
No de la demande: 2018-5487
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0046183 (Report 512168)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: NEW JERSEY
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
Havaneser
1
Homme
12
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Oui
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in 2016, the canine was injured by another canine in the home; unspecified surgery was performed by a veterinarian. On an unspecified date post surgery, in 2016, the canine recovered. On an unspecified date post recovery, in 2016, the canine died. No known 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 the flea control with Seresto on another pet and not to report the death in this event. No further information is expected. This case is closed
Mort
N - Unlikely Trauma is unspecific and in this case was caused due to another canine in the same household, hence it is not product related. 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. Dog involved in this case was geriatric as well. Moreover, the reason for the initial phone call was to discuss the flea control with Seresto on another pet and not to report the death in this event. Finally, even though some information is missing (necropsy, time to onset) considering unexpected fatal outcome and intent of the call a product relation is considered as unlikely.