Nouvelle déclaration d'incident
No de la demande: 2018-1603
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0006781 (Report 473126)
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: ALABAMA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Dog unspecified
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date post application, in approximately 2015, the dog died due to unknown circumstances. 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 use of Seresto on the current pet and not to report the death of the patient. No further information is expected. This case is closed. Note: previouis exposure is well tolerated.
Mort
N-unlikely: 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. Previous exposure was well tolerated. Additionally, reason for initial call was to discuss the use of the product and not to report the death of the patient. In case suspected product involvement adverse event would have been reported in close proximity of the death of the animal not long time after (more than 2 years). Even though some information is missing (e.g. animal details, time to onset and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product involvement is deemed to be unlikely.