Nouvelle déclaration d'incident
No de la demande: 2015-3863
Numéro de référence du titulaire d'homologation: 2015TH274
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Blvd
Ville: Mississauga
État: ON
Pays: Canada
Code postal /Zip: L9W 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 Collar - large dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Non
Autre
Cat / Chat
udomestic short hair
1
Femme
4
5.5
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Inconnu
Oui
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 01-Aug-2013, a 4 year old, 5.5 pound, spayed, female, Domestic Shorthair feline, in fair condition, with a concomitant medical condition of a cornea disorder, had a partial Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 20 Aug 2013 the cat had hair loss, a skin lesion, and pyoderma all at the application site, and had an oral ulcer. On 29 Aug 2013 the cat was seen by the veterinarian, it is unknown if any treatments were performed. The cat died of unknown causes at the clinic. A necropsy had not been performed.
Mort
N - Unlikely. Transient mild application site disorders may occur in particularly sensitive animals shortly after product application. However application site reactions such as pyoderma not expected with product use, but could be related to late observation of local signs and possible self-trauma. Inappropriate application of a part of a large dog collar may have contributed to the signs. Oral ulceration not expected with topical product application in particular since no oral exposure has been reported. Fatal outcome not expected following use of the product. While circumstances and further signs of death are unknown in this case, there is no explanation in the pharm-tox characteristics of the product for any severe reaction or even death. Alternative causes possible while no reasonable connection can be made between death and treatment. Thus product relation is assessed unlikely.