Nouvelle déclaration d'incident
No de la demande: 2018-2273
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0022719 (Report 487306)
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: NEW YORK
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Cat
Autre (préciser)
COLLAROui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Femme
10
6.804
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in approximately 2017, the cat exhibited application site alopecia. On a separate unspecified date in 2017, the cat died. No necropsy was performed. No further information is expected. The case is closed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will they be sought. The reason for the initial phone call was to discuss product use on another animal and not to report the death in this event.
Mort
O - Unclassifiable/unassessable Reported application site alopecia may occur in sensitive animals after product application. It is usually mild and transient. Time to onset unknown, although seems to be quite long. Unclear if the correct use of the collar was checked routinely. Death, however, 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. Time to onset unknown for death. 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. Moreover, the initial phone call was to discuss product use on another animal and not to report the death of this elderly animal. Although a product relation for the application site reaction cannot be ruled out, the death is considered unrelated to the product use. In the end, the case was considered as unassessable.