Nouvelle déclaration d'incident
No de la demande: 2017-2205
Numéro de référence du titulaire d'homologation: 2017KP149
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 - Small Dog
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Shih Tzu/Maltese Crossbreed
1
Femme
14
9
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
An unspecified amount of time post application, in approximately 2014, the dog had application site bleeding and the collar was removed. On an unknown date post collar removal, in approximately 2014, the application site bleeding resolved. Follow up received on 2014-10-20. No further information is expected. This case is closed. Follow up received on 02nd Mar 2017: On an unspecified date in approximately 2014, a 14 year old, 9 pound, neutered, female, Shih Tzu/Maltese crossbred canine, in fair condition, with concomitant alopecia, pruritus, atopy, a fungal skin infection, and hypothyroidism, administered oclcitinib and ketoconazole, had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner. An unspecified amount of time post application, in approximately 2014, the dog had application site bleeding and the collar was removed. On an unspecified date, in 2014, the dog was diagnosed with squamos cell carcinoma. On an unspecified date post diagnosis, in 2014, the dog died. It is unknown if a necropsy was performed. The caller contacted Bayer Animal Health to inquire about product use and not to report this event. No further information is expected. Case is closed.
Mort
Transient mild application site disorders may occur in particularly sensitive animals shortly after product application. However, the described application site bleeding is not expected with product use. Scratching/selftrauma may have contributed to signs. The reported squamous cell carcinoma and death are not expected following appropriate topical product application as inconsistent with products pharmaco-toxicological profile. Oral exposure to the collar is not expected to cause such 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. Animal involved in this case was geriatric, which may have further contributed to the serious signs. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after collar removal (almost after 2 years). Moreover owner does not believe in product connection either as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though some information (e.g. exact time to onset and necropsy report) is not available, sufficient information exists to rule out product relation considering serious outcome of the case. Finally, a product relation is unlikely.