Nouvelle déclaration d'incident
No de la demande: 2021-3190
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2021-US0018656 (Report 699708)
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 collar Small dog
Autre (préciser)
COLLAROui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Chihuahua
1
Femme
8
2.4948
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in Sep2020, the dog was examined by a veterinarian for annual exam and exhibited a musculoskeletal disorder; no treatment was provided. On 03Oct2020, the owner removed the collar, the dog was bathed with an unspecified shampoo and a new Seresto Small Dog (Flumethrin-Imidacloprid) collar was placed around the neck by the owner. Approximately 1 hour post collar placement the dog was taken on a walk and exhibited panting and lethargy. The owner had to carry the dog home. On 04Oct2021, the dog exhibited a seizure, groaning, blood from an unknown, she stopped breathing and died. No necropsy was preformed.
Mort
O - Unclassifiable/unassessable Initially reported musculoskeletal disorder is not expected after appropriate product use. Time to onset is unknown. Other causes should be considered. Reported lethargy and groaning are unspecific signs and may have numerous other causes. Sign may occur initially after collar administration. Further, panting, bleeding, serious signs of seizure, respiratory arrest and fatal outcome of death are not expected following appropriate topical product application as inconsistent with products 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. Time to onset is short after reapplication of collar. Further necropsy details are unknown. Other unrelated causes should be considered. Moreover, previous collar application was well tolerated. Considering all aspects, a product relation is unassessable.