Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1314

2. Registrant Information.

Registrant Reference Number: 2015-395181

Registrant Name (Full Legal Name no abbreviations): Bayer Inc. Consumer Care

Address: 2920 Matheson Blvd. East

City: Mississauga

Prov / State: Ontario

Country: Canada

Postal Code: L4W 5R6

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

Human

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

05-AUG-15

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. 26642      PMRA Submission No. 2015-0085      EPA Registration No. N/A

Product Name: Muskol Insect Repellent Aerosol

• Active Ingredient(s)
  • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO & PARA ISOMERS)

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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 aerosol product was applied directly to the skin as an insect repellent.

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.

Other

2. Demographic information of data subject

Sex: Male

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Inflammation of the skin

4. How long did the symptoms last?

Unknown / Inconnu

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?

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.)

A consumer reported on 05-Aug-2015, that she had applied Muskol aerosol to her son who had a skin wound the size of a pencil eraser. The repellent got into the wound, and the wound then appeared to be the size of a quarter, and looked like a chemical burn. The consumer stated that she did not realize the product was expired at the time, and she did not know until after reading the label that it should not be given to children under the age of 12. She stated that she was not sure if the Muskol was what caused the wound to become bigger. She stated that the wound was already looking better, and not worsening.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.