Nouvelle déclaration d'incident
No de la demande: 2019-5072
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0045885 (Report 588577)
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: TEXAS
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantageII pipette size unknown
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage Spot-on pipette size unknown
Autre (préciser)
spot onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in 2017, the cat developed neoplasia. It was unknown if the cat was examined by a veterinarian or if any treatments were performed. An an unknown date in 2017, post application and post onset of the clinical sign, the cat died. It was not known if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed. Note: The intent of the call was to inquire about product use in general and not to report this event.
Mort
Advantage Plus Spot-on pipette size unknown O - Unclassifiable/unassessable Reported neoplasia and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Animal may have died because of neoplasia. Considering unknown time to onset, product relation for the case is unassessable. Advantage Spot-on pipette size unknown N - Unlikely Reported neoplasia and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Other causes are likely. Considering long time to onset (7 years), relation to product is unlikely.