Nouvelle déclaration d'incident
No de la demande: 2017-4003
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0017638
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
Shih Tzu
1
Homme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Other / Autre
préciser Unknown
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in approximately 2011, a male, Shih Tzu canine, of unknown age, weight and reporductive condition, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unspecified date in 2011, post the application the dog developed application site hot spots. The dog was not examined for the sign by a veterinarian and the issue resolved. On an unspecified date in approximately 2013 the dog died of unspecified causes; no necropsy was performed. No further information is expected, this case is closed. The reporting party contacted Bayer Animal Health to inquire about use of the product for an active flea infestation and not report the death of this animal. Follow up received on 24th Apr 2017: On an unspecified date in 2011, post the application the dog developed application site hot spots. The dog was not examined for the sign by a veterinarian and the issue resolved on an unknown date in 2011.
Mort
N - Unlikely Whereas skin reaction at application site, e.g. pruritus or erythema may occur in sensitive animals, would not expect pyoderma development directly related to product. However, likely linked to scratching at application site which caused skin lesions by self-trauma, which secondarily became infected with bacteria. Death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and time to onset unknown - necropsy not available) as the intent of the phone call to Bayer was to ask if the remaining product could be used on a new pet, and not to report the death of the patient. Other etiologies more probable. No signs of allergy/anaphylactic reaction reported. 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. Time to onset though unknown for initially reported sign, it is too long (approx. 2 years) for later reported death. Considering all aspects, product connection deemed to be unlikely.