Nouvelle déclaration d'incident
No de la demande: 2017-4458
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0025364
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Large
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
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
Système
>3 days <=1 wk / >3 jours <=1 sem
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 01-Oct-2016, a canine of unknown signalment and condition, with no known concomitant medical conditions, had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 23- Nov-2016, the canine was examined by the veterinarian and diagnosed with lymphoma. On approximately 30-Nov-2016, the canine died; no known necropsy was performed. 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. The case is closed.
Mort
N - Unlikely Reported lymphoma and death are 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. Additionally, overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is very long. Death may be the consequence of earlier diagnosed lymphoma in an animal. Further the owner did not believe in product involvement either as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though some information (e.g. animal details, health condition, medical history and necropsy report) is not available, considering chronology and known safety profile of the product, a product relation is unlikely.