Nouvelle déclaration d'incident
No de la demande: 2015-6481
Numéro de référence du titulaire d'homologation: 2015-US-14323
Nom du titulaire (nom légal complet, aucune abbréviation): Virbac Animal Health
Adresse: 3200 Meacham Blvd.
Ville: Fort Worth
État: TX
Pays: United States
Code postal /Zip: 76137
Incident chez un animal domestique
Pays: UNITED STATES
État: ILLINOIS
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 2382-117
Nom du produit: Ecto-Soothe 3x Shampoo 8 oz.
Liquide
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Maine Coon
1
Femme
12
9.5
lbs
Cutanée
<=15 min / <=15 min
>2 hrs <=8 hrs / > 2 h < = 8 h
Système
Anticip. permanent/Permanence anticipée
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 09/25/2015, sponsor was contacted to report an apparent adverse reaction to ECTO-SOOTHE 3X (0.15% pyrethrins, 1.5% Piperonyl butoxide, 0.5% n-Octyl bicycloheptene dicarboximide) Shampoo. According to the animal owner, the cat had developed signs of dermatitis the previous month and fleas were observed one week ago. The cat had been bathed with ECTO-SOOTHE 3X two weeks prior with no reaction noted. On 09/23/2015, the cat was bathed with ECTO-SOOTHE 3X and the cat died that evening. The animal owner stated that the cat had stopped eating and developed very dense, black stools several days prior to its death. The cat was not examined by a veterinarian for the anorexia or melena, and no necropsy was performed. No further information is expected.
Mort
Sponsor veterinarian noted that it is unlikely ECTO-SOOTHE 3X attributed to the cats death due to the previous bath with no reaction, the good margin of safety when use on cats, and the clinical signs that developed prior to the bath on 09/23/2015. ECTO-SOOTHE 3X is not expected to cause death if used according to the label and shampoos with these active ingredients do not commonly cause systemic effects. Sponsor veterinarian noted that due to the cats age and the clinical signs that developed prior to death, an underlying undiagnosed disease, such as neoplasia, metabolic, degenerative, inflammatory/infectious, or trauma, etc, should be considered.