Nouvelle déclaration d'incident
No de la demande: 2016-7962
Numéro de référence du titulaire d'homologation: 2016KP243
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
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Chihuahua
1
Femme
16
12
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in 2015, the dog had a seizure that resolved within approximately 5 minutes and exhibited labored breathing. No medical intervention was sought. On 25 Mar 2015, the labored breathing worsened and the dog died. No necropsy was performed. 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 more information expected. This case is closed.
Mort
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. Time to onset not given, however long as the collar was worn for at least 2 months without causing any adverse signs. Overdose of 5 collars around the neck of 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 did not cause serious signs either. Even with oral product exposure, seizures is not expected. Merely gastrointestinal signs would be possible. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Other causes are more likely. Reported labored breathing and reoccurrence of the same afterwards is not expected as per the product profile. Other causes are more likely for the labored breathing in such a geriatric animal. Death is not expected with product use and likely associated with an underlying condition in this geriatric dog. Moreover, the call was to discuss the use of the product and not to report the death of the patient. Finally, even though some information (e.g. necropsy results, heath status), no plausible connection can be made to the product and a product relation is deemed to be unlikely due to the long time to onset.