Nouvelle déclaration d'incident
No de la demande: 2017-4912
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0039424
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 unknown
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Homme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in approximately 2016, a canine with unknown signalment, in unknown condition, with unknown concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck topically by the owner. On an unknown date in approximately 2016, following the application of the collar, the dog died. No necropsy was performed. 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 use of the product not to report the death in this event. No further information is expected. This case is closed.
Mort
N - Unlikely 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 dogs for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Dog involved in this case was geriatric. Moreover owner does not believe in product connection as the reason for the initial phone call was to discuss use of the product not to report the death in this event. In case of suspected product involvement case would have been reported in close proximity and not after long time (more than 6 months). Though time to onset is unknown, considering known safety product profile a product relation is unlikely.