Nouvelle déclaration d'incident
No de la demande: 2019-6462
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0063116 (Report 606053)
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 collar
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Bullmastiff
1
Inconnu
Inconnu
Inconnu
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
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 approximately Mar 2019, the canine had fleas visualized. The Seresto collar was removed and replaced with an unspecified flea collar. On an unknown date in approximately Apr 2019, the canine was examined by a veterinarian for an unspecified eye issue. On an unknown date in May 2019, approximately 7 weeks post removal of the Seresto collar, the canine died and no necropsy was performed.
Mort
N - Unlikely - SLEE/fleas. Presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Fleas were reported after a flea-free time. Sudden appearance of fleas after flea-free time suggests re-infestation with fleas from environment (e.g. other untreated pets, wildlife). This may lead to new establishment of a flea population in pet's environment requiring several weeks of treatment to disappear. Reported eye disorder and death are not expected following appropriate topical product application as inconsistent with product's 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Previous exposure was well tolerated by animal without any adverse event. Time to onset long. Moreover, animal died long time after collar removal. Other unrelated causes are more probable. Considering all aspects, a relation to this case is considered as unlikely.