Nouvelle déclaration d'incident
No de la demande: 2017-2206
Numéro de référence du titulaire d'homologation: 2017KP150
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 Collar - Cat
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Maine Coon
1
Homme
11
19
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 04-Nov-2014, the cat developed application site bleeding lesion, application site alopecia, application site pruritus, and alopecia on his abdomen. The collar was removed. On 13-Nov-2014, the collar was reapplied. On approximately 27-Nov-2014, the collar was removed. On approximately 01-Jan-2015, the cat's application site bleeding lesion resolved without medical intervention. As of 12-Mar-2015, the cat's application site alopecia, application site pruritus, and alopecia on his belly continued. Follow up received on 17th Mar 2017: On 26-Oct-2014, an 11 year old, 19 pound, neutered, male, Maine Coon Cat feline, in good condition, with excessive grooming behavior, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 04-Nov-2014, the cat developed application site lesion, application site alopecia, application site pruritus, and alopecia on his abdomen. The collar was removed. On 13-Nov-2014, the collar was reapplied. On approximately 27-Nov-2014, the collar was removed. On approximately 01-Jan-2015, the application site lesion resolved without medical intervention; the application site alopecia, application site pruritus, and alopecia on his belly continued. On an unspecified date post removal, in 2015, the cat died. No necropsy was performed.
Mort
The reported application site disorders may occur in sensitive animals after product application. They are usually mild and transient. Skin disorders on other than the application site are not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders like alopecia on the abdomen are not expected. It may be as a consequence to history of excessive grooming. Furthermore signs continued despite collar removal. Death is not expected following appropriate topical product application as inconsistent with products 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. The animal involved was geriatric in this case. Time to onset consistent for initially reported skin disorders, however seems long for later reported death. In case of suspected product involvement case would have been reported in close proximity and not long time after. No necropsy was performed. In spite of application site involvement, considering serious outcome product relation is considered as unlikely.