Nouvelle déclaration d'incident
No de la demande: 2016-4230
Numéro de référence du titulaire d'homologation: 2016KP134
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 - Cat
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
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 administration in 2016, the feline died. It is unknown if any medical intervention was sought or if a necropsy was performed. No further information is expected. This case is closed. Limited information was provided by the reporting party in the initial phone call communication. 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 another pet and not to report the death of the patient.
Mort
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 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Further the owner did not believe in product involvement either as reason for the initial call was to discuss another pet and not to report the death of the patient. Other causes are more likely. In spite of the limited information (animal details, time to onset and medical history of the cat unknown), considering known safety profile of the product sufficient information exists to conclude that the product did not cause the event and a product connection is deemed to be unlikely.