Nouvelle déclaration d'incident
No de la demande: 2017-7476
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0065646 (Report 451444)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: PENNSYLVANIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: (Seresto Large Dog)
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
German Short-haired Pointing Dog
1
Homme
15
43.091
kg
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
Système
>1 mo and <= 2mos / >1 mois et < = 2mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 1 month post application, in approximately Apr-2017, the dog died. No known necropsy was performed. The intent of the call was to inquire about using the product on another animal, not to report this death. No further information is expected, case is closed. Note: Previous exposure was well tolerated by animal.
Mort
N-Unlikely: Reported 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 sign. Previous exposure was well tolerated by the animal. Time to onset is long. Other potential causes are more probable in the geriatric dog. In case suspected product involvement adverse event would have been reported in close proximity of the death of the animal not long time after (after 5 months). Additionally, the owner did not believe in product involvement either as the reason for initial call was to discuss the use of the product and not to report the death of the patient. Considering the known product profile sufficient information exists to conclude that the product did not cause the event and thus a product involvement is deemed to be unlikely. The caller contacted Bayer Animal Health to inquire about collar use on other pet and not to report this event. Case closed