Nouvelle déclaration d'incident
No de la demande: 2019-6455
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0060420 (Report 603460)
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: PENNSYLVANIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Small Dog Collar
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Non
Propriétaire de l'animal
Dog / Chien
Chihuahua
1
Homme
9
9.072
kg
Cutanée
Unknown / Inconnu
>6 mos / > 6 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application in 2018, the collar was removed. On approximately 09-Sep-2019, the dog had 1 Seresto Large Dog (Flumethrin-Imidacloprid) placed around the neck by the owner. On 01-Oct-2019, the dog exhibited the behavior of pulling the head through the collar and removed the collar from himself. Immediately post removal, the dog exhibited falling and weakness. Approximately 5 minutes post removal, the dog collapsed and died. No necropsy was performed. The dog was not examined by a veterinarian and no known treatments were performed.
Mort
O - Unclassifiable/unassessable Reported behavioural disorder and weakness are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Other causes are more probable. Falling is not typically seen with appropriate topical product administration. Further, reported collapse followed by 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 such 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. Moreover, initial collar was well tolerated by the animal and this collar was tolerated without any Problems for several weeks. Time to onset is long. Overall, a product involvement is considered unlikely, however as no alternative case present case classified as unassessable.