Nouvelle déclaration d'incident
No de la demande: 2019-3626
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0035673 (Report 577404)
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 unknown
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Two days post application, in 2019, the canine developed a red mark at an unknown location on the body, started vomiting and became anorexic. The Seresto collar was removed. Five days post application, in 2019, the canine died. No known necropsy was performed. No further information is expected. Case is closed.
Mort
O - Unclassifiable/unassessable Reported erythema on other than the application site is not typically seen with topical product administration. Reported vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility) but mild gastrointestinal signs may occur shortly after product application. Reported anorexia is likely associated with vomiting. Time to onset is consistent. Later reported death is 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. Furthermore, death reported after collar removal. No other signs relating to death reported concurrently. Time to onset is long. Other unrelated causes are more probable. Also some information (e.g. animal details, necropsy report) is missing. Considering all aspects, a product involvement is unassessable.