Nouvelle déclaration d'incident
No de la demande: 2017-4482
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0030782
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: MISSOURI
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Dog Collar unknown size
Autre (préciser)
CollarOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Border Collie
1
Inconnu
Inconnu
Inconnu
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in Apr-2013, a Border Collie canine, of unknown signalment and condition, with the concomitant medical condition of a severe flea infestation, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) placed around the neck by the owner. Approximately 8 months post administration in Dec2013, the collar became hard in texture and was removed. The dog had 1 new Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar was placed around the neck by the owner On an unknown date post administration in 2014, the canine died. It was unknown if the dog was examined by a veterinarian or 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 call was to discuss the product expectations for ticks and not to report the death of the patient.
Mort
N - Unlikely Death is not expected following appropriate topical product application as inconsistent with products 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 dogs for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, the reason for the call was to discuss the product expectations for ticks and not to report the death of the patient. Even though some information is missing (time to onset, state of health, animal age and necropsy details), considering the known safety product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.