Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6946
2. Registrant Information.
Registrant Reference Number: 1-54238979
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
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
08-OCT-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
08-OCT-18
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No. 31984
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Infestop for Cats Over 4kg
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On October 8th, 2018, the caller applied the product onto the cat.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform II: Human Incident Report (A separate form for each person affected)
1. Source of Report.
Data Subject
2. Demographic information of data subject
Sex: Female
Age: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
- Skin
- Symptom - Other
- Specify - numbness on skin
4. How long did the symptoms last?
<=30 min / <=30 min
5. Was medical treatment provided? Provide details in question 13.
No
6. a) Was the person hospitalized?
No
6. b) For how long?
7. Exposure scenario
Non-occupational
8. How did exposure occur? (Select all that apply)
Application
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
Unknown
10. Route(s) of exposure.
Skin
11. What was the length of exposure?
Unknown / Inconnu
12. Time between exposure and onset of symptoms.
<=30 min / <=30 min
13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)
Caller reported using the product on her cat, she got some of it on her nail and experienced numbness in her arm. Call center staff stated that skin exposure may result in irritation and redness, which should gradually subside following irrigation. Call center staff recommended removing contaminated clothing and rinse the exposed skin with water for at least 20 minutes. If symptoms persist or worsen over the next 24 hours, seek medical attention and to call back with any questions or concerns.
To be determined by Registrant
14. Severity classification.
Minor
15. Provide supplemental information here.
Signs were expected to be mild and self-limiting.