Nouvelle déclaration d'incident
No de la demande: 2020-2837
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0030864 (Report 647122)
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: NORTH CAROLINA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar unknown
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: K9advantixII pipette size unknown
Autre (préciser)
COLLAR, spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Australian Shepherd Dog
1
Inconnu
8
Inconnu
Cutanée
>1 yr / > 1 an
<=30 min / <=30 min
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Immediately post application, the dog exhibited rolling and whimpering. One day post application, in 2012, the rolling and whimpering resolved. On an unspecified date post application, in 2012, the dog was examined by a veterinarian and diagnosed with unspecified neoplasia. On an unspecified date post application in 2019, the neoplasia worsened and the dog died. No necropsy was performed. No more information is expected and this case is closed.
Mort
Advantix Plus: O - Unclassifiable/unassessable Reported behavioural disorders are unspecific, however, may be a behavioural response to the feeling caused by the applied product. Time to onset is short. Later diagnosed unspecified neoplasia after product application is not expected. The active ingredients are not listed as mutagenic or carcinogenic. Other causes should be considered. Death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Death in this case likely associated with underlying poor condition due worsening of neoplasia in geriatric status of the dog. No necropsy was performed. Though time to onset is short for initial signs, it is long for other reported signs. Considering overall aspects, a product connection is unassessable. Seresto: N - Unlikely Reported rolling, whimpering and neoplasia were reported prior to product use, ruling out product relation. Worsening of unspecified neoplasia followed by death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Outcome in this case the result of pre-existing neoplasia combined with dog's age. A product connection is considered unlikely