Nouvelle déclaration d'incident
No de la demande: 2017-6540
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0037191
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
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
Pomeranian
1
Femme
7
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 2016, a 7 year old, female, Pomeranian canine, of unknown weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On unknown date in 2016, post applicaitoin, the canine was anorexic and was examined by a veterinarian. It was unknown if treatments were performed. On unknown date in Nov2016, post application, the canine died and 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected, this case is closed.
Mort
N - Unlikely Anorexia is an unspecific sign and may have numerous other causes. Further reported 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. Moreover, owner does not believe in product connection as the reason for call to Bayer was to discuss the use of the product and not to report the death of the patient. Finally, though some information missing (state of health, time to onset and necropsy details), considering that time for reporting is long and known safety product profile, a product connection is deemed to be unlikely.