Nouvelle déclaration d'incident
No de la demande: 2016-4275
Numéro de référence du titulaire d'homologation: 2016KP156
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
Inconnu
Autre
Dog / Chien
Bichon Frise
1
Femme
8
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in Sep2014, post application, the dog died. No known necropsy was performed. 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 phone call was to inquire about the use of the product and not to report the death of the patient. No more information is expected. Case is closed.
Mort
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 signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Other causes are more likely. Further the animal reported in this case was in advanced age, poor condition with the history of unspecified renal disorder which may be cause for death as well. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (2 years). Further, the owner did not believe in product involvement either as reason for the initial call was to inquire about a use of the product and not to report the death of the patient. Considering these aspects, in spite of the limited information (animal details, time to onset, absence of necropsy results), considering known safety profile of the product, product relation is unlikely.