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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0831

2. Registrant Information.

Registrant Reference Number: 2017-147614

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.

28-JUL-17

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)

PMRA Registration No. 26642      PMRA Submission No. 2007-6029      EPA Registration No.

Product Name: Muskol Insect Repellent Aerosol

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

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).

On an unknown date, the patient started Muskol Insect Repellent Aerosol at an unspecified dose and frequency.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Irritated skin
    • Symptom - Other
    • Specify - BUMPS ON SKIN ("getting little bumps on the back of her neck")

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?

Unknown

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.)

This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER ("getting little bumps on the back of her neck") and SKIN IRRITATION ("irritated her skin") in a age-year-old female patient who received MUSKOL INSECT REPELLENT AEROSOL cutaneous spray. CONCOMITANT PRODUCTS included Sunscreen. On an unknown date, the patient started Muskol Insect Repellent Aerosol at an unspecified dose and frequency. On an unknown date, the patient experienced SKIN DISORDER and SKIN IRRITATION. The reporter provided no causality assessment for SKIN DISORDER and SKIN IRRITATION with Muskol Insect Repellent Aerosol. Further company follow-up with the consumer is not possible.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.