New incident report
Incident Report Number: 2023-7018
Registrant Reference Number: 2023-CA-000320 and 2023-CA-000322
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
Unknown
PMRA Registration No. 26493 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Over 14 kg (30 lbs)
Yes
Unknown
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
Australian Shepherd
1
Female
1
23.1
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date, the animal owner applied the product topically to the dog. The product was repeated approximately once monthly for 3 months. Dog developed scratching on an unknown date. No further information is expected.
Minor
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. Signs are expected to be mild and self-limiting.
Animal's Owner
Dog / Chien
Chihuahua
1
Female
3
2.3
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date, the animal owner applied the product topically to the dog. The product was repeated approximately once monthly for 3 months. Dog developed scratching on an unknown date. No further information is expected.
Minor
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. This was extra label use as it was not the appropriate dosage amount for a small sized dog. Signs are expected to be mild and self-limiting.