Nouvelle déclaration d'incident
No de la demande: 2016-2742
Numéro de référence du titulaire d'homologation: 2016KP060
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
Cocker Spaniel
1
Femme
10
32
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 30-Aug-2015, the collar was removed and the dog was bathed with an unspecified shampoo. Approximately 1 hour post collar removal, the dog began having diarrhea, a decreased appetite, polydpsia, alopecia, and was lethargic. On several unspecified dates in 2015, the dog presented to the veterinary clinic for evaluation. The veterinarian performed bloodwork and urinalyses that were normal. It is not known if any treatments were performed. On 30-Oct-2015, the dog died. No necropsy was performed. No further information is expected. This case is closed.
Mort
Diarrhea is an unspecific sign and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure reported. Decreased appetite, polydipsia and lethargy may be associated with diarrhea indicating other unrelated causes. Location of alopecia is unknown, but generalized signs not expected with product use. If any, sign would be localized at the application site. All these sign were reported after collar removal and in close proximity of bathing with shampoo. 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 serious signs or death either. An overdose of 5 collars around the neck was investigated in adult dogs for an 8 months period without causing serious signs. All the signs including fatal outcome was reported after collar was removed. Hence, other unrelated causes are more probable in this geriatric dog. Finally, even though no necropsy was performed, considering chronology and the known product profile, product relation can be ruled out.