Nouvelle déclaration d'incident
No de la demande: 2019-3596
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0031784 (Report 573272)
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Dog (unspecified)
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Shih Tzu
1
Femme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 10-Jun-2019, the dog exhibited anorexia. On 13-Jun-2019, the dog collapsed. The dog was evaluated by the veterinarian, no treatments were performed, and 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 ask if an unopened unit of the product could be refunded for, not to report the event. No further information is expected. This case is closed.
Mort
N - Unlikely Anorexia is unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Collapse and further reported 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. Animal had concomitant medical condition of heart failure which may have contributed to serious outcome. The intent of the call was about refund of the collar and not to report the event. Time to onset is long. Considering overall aspects, product relation is unlikely.