Nouvelle déclaration d'incident
No de la demande: 2017-0555
Numéro de référence du titulaire d'homologation: 2017KP063
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 - Large Dog
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Great Dane
1
Femme
Inconnu
Inconnu
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
The dog was bathed on unknown dates in 2013, approximately every 3 days, with a medicated pet shampoo. On an unknown date in 2013, the pruritus resolved. On an unknown date in approximately May of 2013, the pruritus recurred. On an unknown date in approximately 2013, the dog was administered 1 tube of K9 Advantix II (unspecified) (imidicloprid-pyriproxifen-permethrin) topically by the owner. On an unknown date post product application, in approximately 2013, the pruritus resolved. No more information is expected. This case is closed. Follow up received on 02 Nov 2016: On approximately 01-Jan-2013, a neutered, female, Great Dane, of unknown age and weight, in good condition, with fleas, pruritus, and atopic allergies, bathed approximately every 3 days with a medicated pet shampoo in 2013, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date in 2013, the concomitant pruritus resolved. On an unknown date post application, in approximately May 2013, the pruritus recurred; the collar was removed. On an unknown date post onset, in approximately 2013, the dog was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Pyriproxyfen-Permethrin) topically by the owner. On an unknown date post product application, in approximately 2013, the pruritus resolved. On an unspecified date, in approximately 2014, the dog died. It is unknown if a necropsy was performed. The caller contacted Bayer animal heath to inquire about another pet and not to report this event. No further information is expected. Case is closed.
Mort
Pruritus on other than the application site is not typically seen with topical product administration. Alternative causes (concomitant condition of pruritus and atopic allergies) are probable. 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. Owner does not believe in product connection as the caller contacted Bayer animal heath to inquire about another pet and not to report death of the dog. Time to onset of serious sign (in minimum over 6 month) is much too long. Even though some information missing (necropsy report, animal details), considering the known product profile sufficient information exists to conclude that the product did not cause the event and the product relation is deemed to be unlikely.