New incident report
Incident Report Number: 2020-6063
Registrant Reference Number: 2020-CA-000319
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G 5L3
Domestic Animal
Country: CANADA
Prov / State: ONTARIO
PMRA Registration No. 31980 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Infestop for Cats 4kg and Under
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair Cat
1
Female
3
3.629
kg
Skin
Unknown / Inconnu
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Unknown / Inconnu
No
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 18-Aug-2020 the animal owner applied the product topically to the cat for treatment of an existing flea infestation. Approximately 24 hours after the application, symptoms developed. The owner cleaned the area with water and applied a topical antibiotic infused with aloe. On approximately 26-Aug-2020 the application site developed scabbing. On 28-Aug-2020 application site appeared improved but symptoms had not resolved. No further information is expected.
Moderate
Assessment: Imidacloprid and the inactive ingredients in this product have a wide margin of safety in cats. Mild dermal irritation such as erythema may occur following topical application. Individual sensitivity may occur to either the active ingredient or inactive ingredients. The duration of symptoms is longer than typically expected. Other causes including other product use or prior irritation to the skin from the flea infestation should be considered. 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.