Nouvelle déclaration d'incident
No de la demande: 2020-2242
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0020783 (Report 635821)
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: TEXAS
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar Small Dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Yorkshire Terrier
1
Femme
10
3.629
kg
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 12May2020 the dog developed diarrhea, vomiting, and inability to walk. The dog was examined by a veterinarian and administered 3 unknown injections and placed on intravenous fluids. The dog was released to the care of the owner. Approximately 30 minutes post discharge the dog developed seizure and died. It is unknown if a necropsy was performed.
Mort
O - Unclassifiable/unassessable Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility) but mild gastrointestinal signs may occur shortly after product application. Inability to walk likely associated with digestive disorders. 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/convulsions 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. Further reported fatal outcome of death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Other unrelated causes must be considered in this geriatric animal. Role of concomitantly administered medicaments must be considered in this case. Time to onset is short. Considering low level of information (e.g. health status, medical history and necropsy report are unknown), a relation to this case is considered as unassessable.