Nouvelle déclaration d'incident
No de la demande: 2016-2751
Numéro de référence du titulaire d'homologation: 2016KP069
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
Pomeranian
1
Femme
8
6
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
Système
>2 hrs <=8 hrs / > 2 h < = 8 h
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 24Dec2015, the dog was walking with a hunched back (abnormal posture) and exhibited difficulty walking, so the collar was removed. It is unknown if she was examined or treated by a veterinarian. Approximately 2 hours post removal, the dog recovered. On 30Dec2015, the dog passed away. It is unknown if a necropsy was performed. No further information expected. Case closed.
Mort
Reported neurological signs are not anticipated with appropriate topical product administration. No oral product exposure reported. Even with oral product no neurological signs would be expected. Time to onset of these signs long with 8 days. Animal recovered in a short period of time after removal of the collar which may be coincidental. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Product has wide margin of safety. 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. Animal passed away after long time (6 days) of collar removal. Also animal has concomitant condition of cardiac enlargement which might have contributed to fatal outcome. Considering the known product profile and long time to onset, even though no necropsy was performed, sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.