Nouvelle déclaration d'incident
No de la demande: 2016-6709
Numéro de référence du titulaire d'homologation: 2016KP267
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
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Domestic Medium Hair
1
Homme
8
9
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 04Sep2016, the cat began to hide. On 11Sep2016, the cat exhibited a head tilt, hind limb ataxia, seizures and died. The cat was not examined by a veterinarian and 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 reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected and the case is closed.
Mort
Hiding is unspecific and may have numerous other causes. Head tilt is not expected as inconsistent with the pharamco-toxicological product profile. Sign in this case is likely associated with seizures. The product is not anticipated to cause the neurological disorders and particularly serious ones such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of 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 did not cause serious signs either. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Death is not expected as not in line with the pharmaco-toxicological product profile. Death in this case was likely a consequence of underlying neurological disorder. Time to onset long. Moreover the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though no necropsy results available, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.