Nouvelle déclaration d'incident
No de la demande: 2016-2759
Numéro de référence du titulaire d'homologation: 2016KP077
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 - Small Dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Cairn Terrier Crossbreed
1
Femme
8
12
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Immediately post application the dog exhibited lethargy, anorexia, and diarrhea. On 17-Mar-2016 the dog exhibited ataxia and had a seizure. The collar was removed. No treatments or diagnostics were performed. The clinical signs continued. On 18Mar2016 the dog presented to the veterinarian and collapsed and died. A gross necropsy was performed at the clinic, the findings were liver disease and neoplasia through out the dog. Note: Previous exposure was well tolerated. Follow up received on 17th March 2016: On 16-Mar-2016, a 8 year old, 12 pound, neutered, female, Cairn Terrier crossbred canine, in fair condition, with congestive heart failure, who was treated with unknown medications since approximately 2014, had one Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.
Mort
Diarrhea is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Lethargy and anorexia may be consequence of reported diarrhea. The product is not anticipated to cause serious neurological disorders such as seizure 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 sign either. Even with oral product exposure, seizure would not be expected. Merely gastrointestinal signs would be possible. Any action or treatment may trigger seizures in an animal with a respective disposition. Ataxia may be consequence of reported seizure. Death, collapse, liver disease and neoplasia are signs not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Death was the consequence of concomitant condition of congestive heart failure and later diagnosed liver disease and neoplasia as per the necropsy performed. Moreover the animal reported was in a fair condition which may also be a contributing factor to the death of an animal. Death and collapse occurred after collar removal hence not product related. Though time to onset is short for initial signs however considering the serious outcome as death, the known product profile and previous application of collar well tolerated by an animal, a product connection is deemed to be unlikely.