Nouvelle déclaration d'incident
No de la demande: 2019-2314
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0013989 (Report 556182)
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 Dog (unspecified)
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecifed date in 2019 post application, the dog exhibited seizures and died. It is unknown if treatments or diagnostics were performed. No necropsy was performed. No more information is expected. The case is closed. Follow up received on 26th Apr 2019: On an unspecifed date in 2019 post application, the dog exhibited seizures and idiopathic vestibular syndrome and died.
Mort
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as seizure 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. As pet showed seizures/epilepsy prior to product use, seizures were likely related to this underlying condition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Further, idiopathic vestibular syndrome and death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile however in this outcome may be consequence of reported seizure. Neither animal, nor treatment or product details were provided. Time to onset is unknown. Overall, product involvement is considered unassessable.