Nouvelle déclaration d'incident
No de la demande: 2017-2242
Numéro de référence du titulaire d'homologation: 2017KP181
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: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar - Cat
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Unknown
1
Inconnu
10
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 07Mar2017, the cat got into a fight with another animal and was examined by a veterinarian. The cat was administered an unknown dose of an unspecified medication by mouth daily. Approximately 09Mar2017, the cat exhibited hemorrhaging from his left side and was weak. The cat was examined by a veterinarian and the area was clipped. The cat exhibited a puncture wound. Radiographs were performed, an abnormal finding was visible, and was diagnosed with gun shot wound. No other treatments were performed. On approximately 10 Mar 2017, the cat died and no necropsy was performed. 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. Case is closed.
Mort
Reported haemorrhage, weakness and puncture wound is not expected after product application. Death is not expected either as inconsistent with products pharmacotoxicological profile. Even oral exposure to the collar is not expected to cause serious signs. 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. Reported signs are likely related to diagnosed gun shot wound. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Time to onset is exceptionally long. Considering the known product profile and the diagnosed gun shot sufficient information exists to conclude that the product did not cause the event and product involvement was deemed to be unlikely.