Nouvelle déclaration d'incident
No de la demande: 2016-0743
Numéro de référence du titulaire d'homologation: 2015KP371
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
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Miniature Dachshund
1
Homme
14
15.5
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
Système
>2 mos and <=6mos />2 mois et <=6mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in Sept 2015, the dog developed hind end ataxia, polydipsia, weight loss, loss of hearing and vision. On 01-Dec-2015, the dog had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner as the original had been worn for the labelled 8 months. On 03-Dec-2015, the dog died. No medical intervention was sought for the clinical signs and it is unknown if a necropsy was performed. No further information is expected. This case is closed.
Mort
Ataxia is not anticipated with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure only transient gastrointestinal signs but no neurological signs would be expected. Reported polydipsia, weight loss, loss of hearing and vision are not expected after topical product application as not in line with pharmaco-toxicological product profile. 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 death 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the known product profile and also since the collar was well tolerated for exceptionally long duration of time sufficient information exists to rule out the product involvement. Animal was geriatric which is the more likely cause for the death of an animal. Hence even though if it is unknown whether necropsy was performed, considering all aspects product relation is unlikely.