Nouvelle déclaration d'incident
No de la demande: 2016-2745
Numéro de référence du titulaire d'homologation: 2016KP063
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
Pit Bull
1
Homme
8
80
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 06-Sep-2015, the dog exhibited lethargy, vomiting and tachycardia. The dog continued to wear the collar and the clinical signs would resolve and recur on unspecified dates. On an unspecified date in approximately Sep-2015, the dog was examined by a veterinarian and was within normal limits. No tests or treatments were performed. On approximately 26-Nov-2015, the dog had weight loss. The collar was removed and the clinical signs continued. On 05-Jan-2016, the dog died. No necropsy was performed.
Mort
Reported signs of vomiting, lethargy, tachycardia are unspecific and may have numerous other causes. Long time to onset. No oral product exposure. Symptoms waned in between although the collar remained on the dog. Weight loss is probably consequence of ongoing vomiting and possible underlying conditions. Clinical signs continued even after collar removal. This suggests other unrelated causes. Further, 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. In the end, other causes are more likely as signs went on despite collar removal. Subsequent death was reported very long time (more than 1 month) after collar removal. Finally, considering the known product profile and chronology, a product connection is considered unlikely.