Nouvelle déclaration d'incident
No de la demande: 2016-7942
Numéro de référence du titulaire d'homologation: 2016KP223
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Siamese
1
Homme
6
8
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 22Apr2015 the cat developed application site lesions, application site scabs and application site excessive grooming. On 23Apr2015 the collar was removed. Follow up information received on 6th Jun 2016 : On an unspecified date post collar removal, the feline died. No known necropsy was performed. Limited information was obtained at the time of the communication. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a replacement collar and not to report the death of this animal.
Mort
Transient mild application site disorders may occur in particularly sensitive animals shortly after product application. Signs and time to onset consistent with pharmaco-toxicological product profile. Application site excessive grooming may be a behavioural response to product. 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. Time to onset long. Moreover the intent of the owner was not to report the death of the animal, it was about replacement of collar. Finally, considering known safety product profile, though no necropsy was performed sufficient information exist to rule out the product involvement in the serious outcome and relation remains unlikely.