Nouvelle déclaration d'incident
No de la demande: 2017-4949
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0044611
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 (unspecified)
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Lhasa Apso
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
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 2016, approximately 1 month post application, the collar was removed for an unknown reason. On an unknown date in 2017, the canine died. It was unknown if necropsy was performed.
Mort
Case is closed. The reason for the initial call was to discuss use of the product not to report the death in this event. N-Unlikely: 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. Time to onset is long. However, death occurred unknown time after collar removal. Other causes are more probable. The intent of the call was to discuss use of the product not to report the death in this event. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Though some information is not available (necropsy report and animal details), sufficient information exists to rule out product involvement completely. Overall, product involvement is unlikely.