Nouvelle déclaration d'incident
No de la demande: 2019-4445
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0037118 (Report 579207)
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: TENNESSEE
Inconnu
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
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Homme
10
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post appliction, in Jun-2019, the dog developed an unspecified cardiac disorder and an unspecified kidney disorder. It was unknown if the dog was examined or treated by a veterinarian. On an unspecified date in approximately Jul-2019, the dog died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Reported serious signs of unspecified cardiac disorder and an unspecified kidney disorder leading to serious outcome of death are 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. Other causes are more probable. Moreover, the intent of the call was to inquire about product use in general and not to report this event. No necropsy performed. Time to onset is unknown. Considering overall aspects, product relation is unassessable.