Nouvelle déclaration d'incident
No de la demande: 2019-5935
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0056900 (Report 600266)
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: CONNECTICUT
Inconnu
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
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Miniature Schnauzer
1
Femme
14
Inconnu
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in 2016, the canine had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner that remained on for approximately 8 months and was then removed in 2016. On an unknown date in 2016, the 11 year old canine was examined and diagnosed with cancer on the side of her head. It was unknown if any treatments were performed. On an unknown date in 2019, the canine had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date in 2019, the 14 year old canine was examined by a veterinarian and diagnosed with kidney failure. The canine was treated with enalapril and sotalol. On approximately 12-Aug-2019, the canine died and it was unknown if a necropsy was performed. No further 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. 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 and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. 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. Time to onset is unknown. Abnormal blood results and diagnosed cancer are not expected after product application. Other causes are more probable. Further, diagnosed kidney failure and fatal outcome of death are not expected, either. In this case of geriatric animal, fatal outcome was the consequence of alternative causes (cancer and kidney failure) and thus, sufficient information exists to rule out product involvement. Most of the signs were reported after collar removal. Moreover, time to onset for kidney failure and death was unknown after subsequent collar application. Considering overall aspects product involvement is unlikely.