Nouvelle déclaration d'incident
No de la demande: 2019-0819
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0002668 (Report 544234)
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
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
>3 days <=1 wk / >3 jours <=1 sem
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Persisted until death
Non
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 1 day post application, the canine became lethargic. Approximately 4 days post application, the Seresto collar was removed. Approximately 3 days post removal of the Seresto collar the canine recovered. On an unknown date in Nov 2018, the canine was examined by a veterinarian and unspecified diagnostics were performed, and the canine was diagnosed with an unspecified immune disorder. On an unknown date in Nov 2018, the canine died, and no known necropsy was performed.
Mort
O - Unclassifiable/unassessable - Reported lethargy is unspecific and may have numerous other causes. Time to onset is consistent. Further, reported immune disorder is of unspecific origin and is not expected after topical product use. Immune disorder was reported about one month after collar removal. Therefore, it is rather underlying condition and rather an auto-immune disorder (e.g. systemic lupus erythematous or myasthenia gravis), especially that later the death of animal is reported. Nevertheless, 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 sign either (e.g. death). 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Death reported long after collar removal. Considering limited information (e.g. medical history, animal details and necropsy report), a product relation is unassessable.