Nouvelle déclaration d'incident
No de la demande: 2017-4009
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0018945
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: GEORGIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Small cat
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Unknown
1
Femme
12
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 unspecified date in 2016, a 12 year old, female, Unknown Breed feline, of unknown weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unspecified date Dec-2016, the cat 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected and the case is closed.
Mort
N - Unlikely Reported 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. Other potential causes are more probable in the geriatric animal. The owner did not believe in product involvement either as the 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 (after 3 months). Even though some information is not available (e.g. animal details, health status, medical history and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product involvement is deemed to be unlikely.