Nouvelle déclaration d'incident
No de la demande: 2017-4161
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0035258
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Small Dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Maltese
1
Femme
12
3.629
kg
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
Système
Unknown / Inconnu
Non
Non
Mort
Other / Autre
préciser Unknown
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in approximately Apr2017, a 12 year old, 8 pound, neutered, female, Maltese canine, in unknown condition, with a concomitant medical condition of an unspecified cardiac disorder, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around her neck by the owner. On approximately 17Jun2017, the canine exhibited intermittent vomiting and diarrhea. She was not examined or treated by a veterinarian. 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 product and not to report the death of the patient. On 19Jun2017, the canine died. A necropsy was not performed.
Mort
N - Unlikely Reported vomiting and diarrhoea are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Further, 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 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. Thus other causes are more likely. Animal was geriatric with pre existing medical condition of unspecified cardiac disorder which may have contributed to the fatal outcome. Time to onset long. Moreover, the reason for the initial phone call was to discuss the product and not to report the death of the patient. Even though some information is not available (e.g. necropsy report), considering the known safety profile of the product, sufficient information exists to rule out product relation completely. Overall, a product relation is considered as unlikely.