Nouvelle déclaration d'incident
No de la demande: 2017-6501
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0035774
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: NEW JERSEY
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
Autre
Dog / Chien
Boxer (German Boxer)
1
Femme
12
36.287
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Persisted until death
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the product efficacy and not to report the death of the patient. On an unknown date in approximately 2015, a 12 year old, 80 pound, female, Boxer canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date post application, in approximately 2015, the canine was diagnosed with an unspecified oral cancer. The product was applied approximately every 4 weeks, with the most recent dose on an unknown date in approximately 2016. On an unknown date post application, in approximately 2016, the canine died. No known necropsy was performed. No further information expected. Case closed.
Mort
N - Unlikely Reported death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (time to onset unknown - necropsy not available) as the intent of the phone call to Bayer was to discuss the product efficacy and not to report the death of the patient. Dog likely died due to diagnosed oral cancer. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Considering all aspects, product connection deemed to be unlikely.