Nouvelle déclaration d'incident
No de la demande: 2016-4224
Numéro de référence du titulaire d'homologation: 2016KP128
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
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar - Dog
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Labrador Retriever
1
Femme
14
60
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 1 week post application, in 2015, the dog was anorexic, vomiting and lethargic. The owner removed the collar. Approximately 17 days post application, in 2015, the dog recovered without medical intervention. On an unspecified date in 2015, the dog died. No known necropsy was preformed. 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 call was to discuss the reaction to the Seresto collar, and not to report the death of the patient. No more information is expected. This case is closed.
Mort
Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure occurred. Lethargy and anorexia may be consequence of vomiting. 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 death 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. Animal reported in this case was geriatric (14 years) which may be the likely cause for the death of an animal. Moreover, reason for the initial call was to discuss the reaction to the Seresto collar, and not to report the death of the patient. Time to onset is quite long. Death occurred after collar removal. Overall, considering all aspects a product relation is unlikely.