Nouvelle déclaration d'incident
No de la demande: 2017-0579
Numéro de référence du titulaire d'homologation: 2017KP082
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 - Large Dog
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Beagle
1
Homme
12
23
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 27Oct2016, the canine was ataxic and blind. On 03Nov2016, the canine was losing weight so the owner started feeding the canine unknown canned food and treats. On 05Nov2016, the canine developed application site pruritus and application site irritation, so the collar was removed. On 07Nov2016, the canine developed anorexia, adipsia, lethargy and had a brown discharge from his penis. The dog was not examined by a veterinarian. On 09Nov2016, the canine died. No known necropsy was performed. No more information is expected and this case is closed.
Mort
Ataxia is not anticipated with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs but no neurological signs would be expected. Time to onset is short though. Blindness and weight loss are not expected after product application as not in line with pharmacotoxicological product profile. The reported application site disorders may occur in sensitive animals after product application. They are usually mild and transient. Anorexia and lethargy are unspecific signs and may have various other causes. Brown discharge from penis is also not expected after product application. 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. Animal involved in this case was geriatric which may have contributed to blindness and death of the animal. Time to onset is long. Finally, even though some information (e.g. necropsy results) missing, considering the serious and most prominent signs death and blindness, no plausible connection can be made to the product and a product relation is deemed to be unlikely.