Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0239

2. Registrant Information.

Registrant Reference Number: 1307CAN017112

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.

23-JUL-13

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

22-JUL-13

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 the product on her body.

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing
  • Symptom - Burning throat

• Gastrointestinal System
  • Symptom - Burning mouth

• Skin
  • Symptom - Other
  • Specify - burning lips

• General
  • Symptom - Sweating
  • Symptom - Malaise

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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.

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 purchased Muskol insect repellent pump spray while vacationing in Canada. On 22-JUL-2013 while hiking, the consumer sprayed the product on her body, she was then coughing a lot and not feeling well. She perspired considerably and at approximately 5 PM, she experienced coughing, burning on the lips, and in the mouth and throat. The consumer called Poison Control and was told she may be hypersensitive to DEET and to avoid it in the future. The outcome of coughing a lot, not feeling well, perspired considerably, burning lips, burning in mouth and burning in throat was reported as recovered.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The reporter considered the events to be related to Muskol.