Nouvelle déclaration d'incident
No de la demande: 2015-6315
Numéro de référence du titulaire d'homologation: 2015KP320
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Boulevard
Ville: Missisaugua
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. 11556-155
Nom du produit: Seresto Collar - unknown dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Beagle
1
Femme
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
>24 hrs <=3 days / >24 h <=3 jours
Inconnu
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in approximately 2014, the dog began staring at the wall (behavioral disorder NOS). Approximately 2 days after the behavioral sign began, the dog had a seizure, then died. It is not known if a necropsy was performed. Limited information was provided by the reporting party in the initial phone communication. Attempts to obtain more specific details have been unsuccessful to date. No further information is expected. This case is closed.
Mort
Reported behavioural signs are unspecific and may have various other causes. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of adult dogs for an 8 months period did not cause serious signs either. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. 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 death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Exact time to onset is unknown. Also, it is unknown if necropsy was performed. Though product involvement was deemed unlikely, due to limited information, product relation is deemed to be unassessable.