Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2103

2. Registrant Information.

Registrant Reference Number: 1-61146839

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: N1G5L3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

22-MAY-20

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea & Tick Shampoo for Dogs & Cats

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

A year ago, the caller used the product, on herself, as a shampoo, once, by accident.

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: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Dizziness
  • Symptom - Agitation
  • Symptom - Other
  • Specify - Abnormal Mentation
  • Symptom - Other
  • Specify - tingling sensation in her brain

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>6 mos / > 6 mois

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.)

A year ago, the caller inappropriately used the product on herself as a shampoo, once, by accident. For the past 3-4 months, she's been experiencing symptoms. No medical care was sought.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

This is highly unexpected effect of product exposure. Product not used as per label's instructions. 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.