Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6038

2. Registrant Information.

Registrant Reference Number: 1-57393914

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.

18-JUL-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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)

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PMRA Registration No. 31984      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Infestop For Cats Over 4kg

• Active Ingredient(s)
  • IMIDACLOPRID

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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).

Owner applied the product onto his cat and inappropriately rubbed it in with his bare finger.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Numbness
  • Symptom - Headache

4. How long did the symptoms last?

<=30 min / <=30 min

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

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.)

On an unknown date, the owner applied the product onto his cat and rubbed it in with his bare finger after the application. Shortly after the application, his finger felt numb so he washed it and started to get a headache. The Pro-Pharma agent said that inhalation of this product may lead to nausea, headache, difficulty breathing and shortness of breath. Adverse health effects are typically limited to the upper respiratory tract and resolve without affecting other body functions. The agent stated that skin exposure may lead to irritation or redness, which should gradually subside. The agent recommended the caller 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. This was off label use of the product, label directions were not followed in the application to the cat.