Nouvelle déclaration d'incident
No de la demande: 2017-0578
Numéro de référence du titulaire d'homologation: 2017KP081
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 - Cat
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Unknown
1
Homme
12
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in May-2016, the cat exhibited intermittent vomiting. On an unspecified date in Jun-2016, the cat exhibited a constipation and was examined by a veterinarian. Radiographs were performed and the cat was diagnosed with a partial intestinal obstruction. On an unspecified date in Aug-2016, the cat was diagnosed with multiple organ failure. On 27-Aug-2016, the cat was examined by an emergency veterinarian, went into cardiac arrest, and 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 reason for the initial phone call was to expiration date not to report the death of the patient. No further information is expected. Case is closed.
Mort
Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Mild gastrointestinal signs may occur shortly after product application, however, time to onset of sign is unknown. No oral product exposure reported. Constipation is not anticipated with appropriate topical product administration. In this case it is likely associated with the later diagnosed partial intestinal obstruction. The reported serious signs like multiple organ failure, cardiac arrest and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Time to onset is unknown, however, seems long. 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. Moreover, the reason for the initial phone call was to ask for expiration date and not to report the death of the patient. Animal involved in this case was geriatric which may have further contributed the signs. Even though some information is not available (health status, medical history, time to onset and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product relation is considered as unlikely.