Nouvelle déclaration d'incident
No de la demande: 2017-4914
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0039726
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: GEORGIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Small Dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
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 unspecified date in approximately 2015, a dog, of unknown signalment and condition, with no known concomitant medical conditions, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On an unspecified date in approximately 2016, post collar application, the dog died. The dog was not examined by a veterinarian. No known 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 product use with another animal and not to report the death in this event. No further information is expected; the 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. Exact time to onset is unknown, however it seems long. The reason for the initial call was to discuss product use with another animal and not to report the death in this event. Finally, even though some information is missing (animal information, state of health, concomitant medical condition and necropsy details), considering the known product safety profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.