Nouvelle déclaration d'incident
No de la demande: 2020-4258
Numéro de référence du titulaire d'homologation: 2020-CA-000175 and 2020-CA-000176
Nom du titulaire (nom légal complet, aucune abbréviation): Wellmark International
Adresse: 100 Stone Road West, Suite 111
Ville: Guelph
État: Ontario
Pays: Canada
Code postal /Zip: N1G5L3
Incident chez un animal domestique
Pays: CANADA
État: BRITISH COLUMBIA
ARLA No d'homologation 31984 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: Zodiac Infestop for Cats 4kg and Over
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Ragdoll
1
Homme
2
4.99
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Unknown/Inconnu
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 22-May-2020 the product was applied topically to the cat by the animal owner. On 5-June-2020 the cat became symptomatic. The cat was attacked by a raccoon at an unspecified date after product application. The cat had an ongoing flea infestation prior to product use. Veterinary care was recommended.
Modérée
Assessment: This product has a wide margin of safety in cats and is not expected to cause the clinical signs described. The trauma and possibly secondary infection may contribute to the other clinical signs depending on severity of the attack. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.
Propriétaire de l'animal
Cat / Chat
Ragdoll
1
Homme
2
2.268
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Unknown/Inconnu
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 22-May-2020 the product was applied topically to the cat by the animal owner. This cat is less than the labelled weight of 4 kg and the animal owner applied less than a full tube of the product. On 5-June-2020 the cat was unthrifty. The cat had an ongoing flea infestation prior to product use. Veterinary care was recommended. No further information is expected. Symptoms expected to be mild and self-limiting.
Mineure
The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.