Nouvelle déclaration d'incident
No de la demande: 2018-0931
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0002702 (Report 468571)
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: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Bichon Frise
1
Homme
Inconnu
Inconnu
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
Immediately post application, the dog had the collar stuck in it's fur then immediately exhibited agitation and abnormal behavior. The owner removed the collar and the clinical signs immediately resolved without medical intervention. On an unspecified date in Nov2017, the dog died. 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 expiration of the product for use on another animal and not to report the death in this event. No known necropsy was performed. No further information is expected. The case is closed.
Mort
N - Unlikely Reported behavioural signs are unspecific and may have numerous other causes. Signs may occur initially after collar administration, however in this case occurred as collar stuck in fur. Further, 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. Moreover, the reason for the initial phone call was to discuss the expiration of the product for use on another animal and not to report the death in this event. Time to onset is short for initial reported signs but is long for later reported death. Even though some information is not available,(e.g. Animal details, Necropsy report) and initially reported signs seems to be product related considering that serious outcome is not product related, a product relation consider as unlikely.