Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8216

2. Registrant Information.

Registrant Reference Number: 1-46014551

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road W, 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.

22-OCT-16

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

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. 31445      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea & Tick Collar For Dogs

• Active Ingredient(s)
  • TETRACHLORVINPHOS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 15, 2016 caller placed collar on her dog.

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

• Gastrointestinal System
  • Symptom - Other
  • Specify - Caller unable to taste

• Eye
  • Symptom - Burning eye

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Unknown

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.

>24 hrs <=3 days / >24 h <=3 jours

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 October 15, 2016 caller placed collar on her dog. She developed symptoms a few days later that resolved. She said she has not be able to taste since that day. She called her doctor and he recommended her calling product hotline to see if there was anything that could be recommended to counteract the product. She did not have ocular or oral exposure, she only placed the collar on her dog.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

These symptoms are unlikely related to the product. The symptoms are not indicative of toxicity from the active ingredient. Caller had little contact with the product so not even irritation is expected from the exposure. Recommended caller to follow up with her doctor and look for other potential causes. This is an unexpected effect and is not related to the use of the product as she described.