Nouvelle déclaration d'incident
No de la demande: 2019-3625
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0035593 (Report 576996)
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: PENNSYLVANIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Cat (Flumethrin-Imidacloprid)
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
unknown
1
Femme
8
7.71
kg
Cutanée
>2 hrs <=8 hrs / >2 h <=8 h
>2 hrs <=8 hrs / > 2 h < = 8 h
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 6 hours post application, the cat exhibited convulsions and died. No known necropsy was performed. Follow up information received on 29th Jun 2019 : The collar had an oily and greasy feeling compared to the previously used collar. Approximately 6 hours post application, the cat exhibited convulsions and died. No known necropsy was performed.
Mort
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as convulsions after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Further, 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Animal may have died due to reported convulsions. Time to onset is short. Although, no necropsy performed. Product relation for the case is unassessable.