Nouvelle déclaration d'incident
No de la demande: 2018-3601
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0037469 (Report 504374)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: NORTH CAROLINA
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
Inconnu
Propriétaire de l'animal
Dog / Chien
unknown
1
Inconnu
6
Inconnu
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>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 30-Jun-2018, the canine was left in an non-air conditioned house and died from hyperthermia. No known medical intervention or necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to request product refund and was not to report the death of the patient. Note: Previous exposure was well tolerated by the animal.
Mort
N - Unlikely Reported hyperthermia and death are 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. The previous exposure was well tolerated by the animal. The canine was left in an non-air conditioned house and died from hyperthermia. Moreover, the reason for the initial call was to request product refund and was not to report the death of the patient. Time to onset is short. Although, no necropsy was performed, considering all aspects, a product involvement is unlikely.