New incident report
Incident Report Number: 2023-4847
Registrant Reference Number: 2023-CA-000242
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: MANITOBA
PMRA Registration No. 26494 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Powerspot Flea and Tick Control for Dogs Under 14kg
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Poodle
1
Male
13
4.5
kg
Skin
>3 days <=1 wk / >3 jours <=1 sem
>3 days <=1 wk / >3 jours <=1 sem
System
Unknown / Inconnu
Yes
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 01 Jun 2023, an unspecified amount of the product was applied to the dog. On 07 Jun 2023, the dog was evaluated by a veterinarian for unspecified symptoms. The dog was started on metronidazole and animal owners were instructed to feed the dog a bland diet. Blood work and an ultrasound were performed, results were unknown by the reporter. Gas was present in the gastrointestinal tract on the ultrasound images. No further information is expected.
Moderate
Assessment: This product has a wide margin of safety. Mild dermal irritation is possible following topical use. If ingested, mild self-limiting GI irritation may develop. Further information such as clinical signs, diagnostics, and response to treatment, would allow for further assessment of causality. Further information is not available. 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.