Nouvelle déclaration d'incident
No de la demande: 2020-2825
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0027081 (Report 642883)
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: NEW JERSEY
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Small Dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Crossbred (Spaniel x Continental Toy x Papillon)
1
Homme
10
7.711
kg
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 01-Jun-2020, the dog developed decreased appetite, urinated on bathroom floor, was uninterested in going on his morning walk, lethargy, panting, had two seizures, bloated abdomen, unconsciousness, stopped breathing and passed away on his own while on the way to the emergency veterinary facility. The dog was evaluated by a veterinarian after he passed away and no treatment had been performed. No necropsy was performed. No further information is expected. This case is closed. Note: No quality issues were noted upon product investigation
Mort
O - Unclassifiable/unassessable 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, however, seizures were reported in connection with product use in dogs. Nevertheless, 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. Other reported signs like decreased appetite, inappropriate urination, behavioural disorder, lethargy, panting, bloated abdomen, unconsciousness, stopped breathing are associated with reported seizures. Further, death is not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Moreover, animal involved in this case is geriatric may be died because of seizures. Time to onset is short. Ovearall, a product relation to the case is unassessable.