Nouvelle déclaration d'incident
No de la demande: 2017-4010
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0019100
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: FLORIDA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Dog Collar unknown size
Autre (préciser)
CollarOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Chihuahua
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 approximately 07-Jun-2016, a Chihuahua canine, of unknown signalment and condition, with concomitant medical conditions of fleas and pruritus, being administered flea dip solution weekly and a flea powder every 2 weeks since approximately May 2016, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date post collar administration in 2016, the canine died. It is unknown if a necropsy was performed. No further information is expected. This case is closed. 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 and not to report the death of the patient.
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 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. Also, the reason for the initial call was to discuss use of the product and not to report the death of the patient. Moreover, no signs of anaphylaxis reported which would have occurred in close proximity to the collar application and not long time after. Though some information is not availabale (e.g. state of health, age, time to onset and necropsy result) considering the known safety profile of the product, a product relation is unlikely.