Nouvelle déclaration d'incident
No de la demande: 2018-1233
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0003932 (Report 469885)
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 YORK
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: K9 AdvantixII pipette size unknown
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Dog unspecified
Autre (préciser)
Spot-on and CollarOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Beagle
1
Femme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in 2014, the canine died. It is unknown if a necropsy was performed. 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. Case is closed.
Mort
Advantix: N-Unlikely: Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Time for reporting is too long (4 years) as the intent of the phone call to Bayer was to discuss the use of the product and not to report the death of the patient. Other etiologies more probable. 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. Finally, though low level of information available (medical history, age and time to onset is unknown), considering known product safety profile, a product connection is deemed to be unlikely. Seresto: N-Unlikely: Reported 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 sign 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. No signs of anaphylaxis reported. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 4 years). Other unrelated causes are more probable. Further, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Overall, even though low level of information (e.g. time to onset), considering safety profile of the product and fatal outcome, a product relation is unlikely.