Nouvelle déclaration d'incident
No de la demande: 2020-2824
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0026352 (Report 642204)
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: ILLINOIS
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Crossbred (German Boxer x Great Dane)
1
Homme
10
63.503
kg
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 30-Apr-2020, the dog exhibited ataxia and tremors. On 05-May-2020, the dog died. The dog had not been evaluated by a veterinarian and during burial the owner noted an application site rash under the collar. No necropsy was performed. No more information is expected. This case is closed. No quality issues were noted upon product investigation.
Mort
O - Unclassifiable/unassessable Reported neurological signs are not typically seen with appropriate topical product administration. Further, reported application site rash may occur in sensitive animals after product application. It is usually mild and transient. Unclear if correct fit of collar was checked periodically as recommended in the product information and thus development of signs not noticed. 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. Other causes are more probable, although not described. Time to onset is long. In this case, product involvement is deemed to be unlikely. However considering limited information such as necropsy details, health status etc. case is considered unassessable.