Nouvelle déclaration d'incident
No de la demande: 2019-5926
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0054528 (Report 597348)
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: INDIANA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar unknown
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in approximately Aug-2018, the dog developed generalized pruritus. On an unspecified date in approximately Feb-2019, the collar was removed due to end of use. On an unspecified date in Feb-2019, the dog was administered a fipronil topical flea and tick preventative once a month by the owner. On an unspecified date in approximately Jun-2019, the dog died. No necropsy was performed. Due to the sensitive nature of the communication, specific, relevant details were not obtained nor will they be sought. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Reported pruritus on other than the application site is not typically seen with topical product administration. Time to onset is long. Other causes (e.g. allergies) are more probable although not described. Further reported 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. No necropsy was performed and death is reported very long time after collar removal. Thus, other unrelated causes are more probable. Furthermore, the intent of the call was to inquire about product use in general and not to report this event. Considering all aspects, product involvement is unassessable.