Nouvelle déclaration d'incident
No de la demande: 2018-1234
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0003933 (Report 469991)
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. Inconnu
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 2016, the canine had generalized pruritus. On an unknown date in 2016, 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: Pruritus is not expected to be generalised but rather be linked to the application site. 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 discuss the use of the product and not to report the death of the patient. 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 and not long time after (approximately 2 years). Other etiologies more probable. Considering all aspects, product connection deemed to be unlikely. Seresto: N-Unlikely: Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) have to be considered as well. Initial pruritus may represent a reaction to the collar in a sensitive animal. 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 signs 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 2 years). Moreover, the owner does not seem to believe in product relation as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Though time to onset is unknown, considering known product safety profile and intent of the call, a product relation is considered unlikely.