Nouvelle déclaration d'incident
No de la demande: 2017-4163
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0035453
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: NORTH CAROLINA
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: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Chihuahua
1
Femme
10
3.629
kg
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 11-May-2017, a 10 year old, approximately 8 pound, neutered, female, Chihuahua dog, in unknown condition, with concomitant congestive heart failure, administered furosemide, pimobendan, and enalapril since approximately 2016, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On 12-May-2017, the dog died. No necropsy was performed.
Mort
N - Unlikely Reported serious systemic sign of death is not expected following appropriate topical product application as it is 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Animal is a geriatric patient with a concomitant medical condition of congestive heart failure which could have resulted in the serious sign. Overall, even though time to onset is short and no necropsy was performed considering known safety profile of the product and the serious outcome of death product relation is deemed to be unlikely.