Nouvelle déclaration d'incident
No de la demande: 2019-3135
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0022791 (Report 564170)
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: WISCONSIN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog (Flumethrin-Imidacloprid) collar
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Border Collie X crossbred
1
Homme
13
36.287
kg
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 15-May-2019, the dog exhibited the behavior of not wanting to go outside, not urinating and the behavior of not defecating. On 16-May-2019, the dog exhibited lethargy, muscle weakness, panting and increased drinking. The not urinating resolved. The collar was removed. No medical intervention was sought and the clinical signs continued. Follow up received on 21 May 2019: On 16-May-2019, the collar was removed and the canine died approximately 3 hours post collar removal. No medical treatment was sought and no known necropsy was performed.
Mort
O - Unclassifiable/unassessable Reported behavioural disorders and lethargy are unspecific signs and may have numerous other causes. Signs may occur initially after collar administration. Further, reported panting, increased drinking and muscle weakness are not expected after appropriate product application. 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. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is consistent. Other causes should be consider in this geriatric dog. Considering overall aspects, a product connection for the case is considered unassessable.