Nouvelle déclaration d'incident
No de la demande: 2018-3588
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0042284 (Report 508468)
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: TEXAS
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Cat
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Homme
Inconnu
Inconnu
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 15-Apr-2017, the cat exhibited the behavior of not wanting to hunt and lethargy. On approximately 15-May-2017, the cat died. No necropsy was performed. Due to the sensitive nature of the communication, certain relevant details were not obtained, nor will such be sought. The reason for the initial communication was to discuss use of the product and not to report the death in this event. No further information is expected. This case is closed. Note: Previous exposure was well tolerated by animal.
Mort
N - Unlikely Reported behavior of not wanting to hunt and lethargy are unspecific and may have numerous other causes. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (almost a year). Moreover, the owner did not believe in product involvement either as the reason for the initial communication was to discuss use of the product and not to report the death in this event. Further, previous exposure was well tolerated by animal. Time to onset is long. Even though no necropsy was performed, considering all aspects, a product involvement is considered unlikely.