Nouvelle déclaration d'incident
No de la demande: 2019-4458
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0041871 (Report 584399)
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Cavalier King Charles Spaniel
1
Homme
8.5
15.87
kg
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 19-Jul-2019 the canine was ataxic and the collar was removed. On 21-Jul-2019 the canine died at home. No necropsy was performed. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Reported ataxia is not typically seen with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Time to onset is rather indicative of a mere behavioural reaction to the collar than a true neurological condition. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, animal died after 2 days of collar removal. Other unrelated causes must be considered in this case. Considering the product profile, product involvement is deemed unlikely regarding death of the animal, however due to limited information (e.g. health status and medical history are unknown), case is considered unassessable.