Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0259

2. Registrant Information.

Registrant Reference Number: 2012SP015711

Registrant Name (Full Legal Name no abbreviations): Merck Canada Inc.

Address: 16750 Transcanada

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

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

Human

4. Date registrant was first informed of the incident.

19-MAR-12

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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. 26912      PMRA Submission No.       EPA Registration No.

Product Name: Muskol insect repellent pump spray

• Active Ingredient(s)
  • DEET PLUS RELATED ACTIVE TOLUAMIDES

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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: Personal use / Usage personnel

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

The consumer sprayed it on his legs and arms.

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: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Erythema
  • Symptom - Other
  • Specify - Localised infection

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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.

Unknown / Inconnu

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.)

The consumer got bitten by the mosquitoes in Cuba and the next morning, his arms were red and infected but not the legs. He reported that now it's OK and the doctor gave him cortisone cream as treatment.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Patient believes it could be due to the Muskol.