Nouvelle déclaration d'incident
No de la demande: 2017-4475
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0028996
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 unknown
Autre (préciser)
collarOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Femme
15
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Oui
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 10-May-2017, a 15 year old, of unknown weight, unknown, female, Unknown (dog) dog, in unknown condition, with concomitant medical conditions of 1 past seizure, had 1 collar Seresto (unspecified) (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On 27May2017 the dog a seizure. On 28May2017 the dog had 2 seizures and the collar was removed.The dog was bathed with dish soap as per veterinarian instructions via a phone consultation. On 30May2017, the dog passed away. No necropsy was performed. Follow up received on 5th May 2017: On 30May2017, the dog died. No necropsy was performed. No more information is expected. This case is closed.
Mort
N - Unlikely 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. But seizures were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. As pet showed seizures prior to product use, seizures are likely related to this underlying condition. It is known that despite adequate treatment, seizures may occur and medication must be adapted every now and then to control the disease. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Reported 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 sign either. Dog involved in this case was geriatric thus numerous other health problems have to be considered in this dog. Finally, even though some information (e.g. necropsy results) is not available, considering known safety profile of the product and fatal outcome, a product involvement is deemed to be unlikely.