Nouvelle déclaration d'incident
No de la demande: 2015-3835
Numéro de référence du titulaire d'homologation: 2015KP189
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Boulevard
Ville: Missisaugua
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
Domestic Shorthair
1
Homme
6
10
lbs
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
Système
>1 mo and <= 2mos / >1 mois et < = 2mois
Oui
Oui
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 29Jun2014 the feline was biting at the collar (application site pruritus) and on his ventral neck he had application site erythema, application site inflammation, and application site alopecia. The owner cut the collar off of him. On 02Jul2014 the feline was examined by a veterinarian and treated with an unspecified dose of injectable methylprednisolone acetate and an unspecified dose of oral spinosad. On 03Jul2014 the feline was no longer biting at the application site (application site pruritus) and the application site erythema and application site inflammation were improved. Follow-up received on 2014-09-29:On 02Jul2014 the feline was examined by a veterinarian and treated with an unspecified dose of injectable methylprednisolone acetate, an unspecified dose of oral spinosad, and subcutaneous fluids. On 03Jul2014 the feline no longer exhibited application site pruritus and the application site erythema and application site inflammation were improved. The cat was negative for feline leukemia. On 05-Aug-2014, the cat had respiratory distress. The cat was examined by the veterinarian and was found to have bicavitary effusion involving the thorax and the abdomen. A thoracocentisis was performed and the cat was administered an injection of cefovecin sodium. On 07-Aug-2014, the cat had respiratory distress recur. The cat was examined by a veterinarian and had a thoraconcentisis performed. The cat had an ultrasound performed and was found to have an abdominal mass present. On approximately 14-Aug-2014, the cat had respiratory distress recur and the cat died on its own before medical attention could be sought. No necropsy was performed. Follow-up received on 29th Oct 2014: No more information is expected. This case is closed.
Mort
N - Unlikely. Transient mild application site disorders e.g. application site pruritus, application site erythema, application site inflammation and application site alopecia may occur in sensitive individuals shortly after product application. Signs and time to onset consistent with pharmacotoxicological product profile. Respiratory distress, thoracic effusion and abdominal effusion are not expected, as not line with pharmaco-toxicological product profile. These signs started more than one month after collar removal and thus were considered not product related. Death is also not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Signs of respiratory distress and thoracic and abdominal effusion with subsequent death are likely the result of the diagnosed abdominal mass but not product related. Although initial application site reaction was product related, the serious signs and subsequent death were unlikely product related. In the end, the case was classified as unlikely.