Nouvelle déclaration d'incident
No de la demande: 2017-4018
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0021409
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: VIRGINIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Small
Autre (préciser)
collarOui
Autres unités: cm
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Yorkshire Terrier
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 2016, a male, Yorkshire Terrier canine, of unknown signalment, 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 approximately 21Apr2017, the dog died. No known medical exams werer performed and it was unknown if a 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. Note: Previous applications were well tolerated.
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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Time to onset long. Also, animal had used product before which was well tolerated. Though some information is unavailable (state of health and necropsy detail) considering the known product safety profile, a product involvement is considered unlikely.