Nouvelle déclaration d'incident
No de la demande: 2020-2833
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0029664 (Report 645871)
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: MISSISSIPPI
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 Poodle
1
Femme
Inconnu
4.082
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Non
Mort
Contact treat.area/Contact surf. traitée
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in 2020 post collar placement, the dog developed inappetence, a behavioral change, lethargy, weight loss, vomiting, and seizures. The dog was examined by a veterinarian and it is unknown if any treatment was preformed. On an unspecified date in 2020 post veterinary exam, the dog died. It is unknown if a necropsy was preformed. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Reported inappetence, behavioral change and lethargy and weight loss are unspecific and may have numerous other causes. Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Time to onset of signs is unknown. Reported signs maybe associated with further reported seizures. 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-month 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. Further reported fatal outcome of death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile and most likely consequence of the reported seizures. However, considering most of the information is not available (animal age, health status, time to onset and necropsy report), product relation is assessed as unassessable.