Nouvelle déclaration d'incident
No de la demande: 2017-7482
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0067068 (Report 453307)
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
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: K9 advantix II pipette size unknown
Autre (préciser)
spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Femme
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>30 min <=2 hrs / >30 min <=2 h
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 1 hour post application the canine had applications site swelling. One month post application in 2013, the owner reapplied the K9 Advantix II (unspecified) and the application site swelling worsened. One month post application he owner reapplied the K9 Advantix II Unspecified and the application site swelling worsened. The canine was then examined by a veterinarian and switched to fipronil. On an unknown date in 2013, the application site swelling resolved. On an unknown date in 2013, the canine had a ruptured mass on the heart. The canine was examined by a veterinarian and the chest was tapped. The canine then died. No known necropsy was performed.
Mort
N - Unlikely Would not expect swelling development at application site directly related to product, however, dog may have scratched at site and caused sign by self-trauma, though scratching at application site was not reported. Further reported ruptured mass on heart and death are not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes are more probable. Death in this case, might be associated with ruptured mass on heart. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 4 years). Finally, though time to onset for initial sign is short and even though some minor information missing (age, medical condition, necropsy details are unknown), considering known product safety Profile and fatal outcome, a product connection is deemed to be unlikely.