Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0689

2. Registrant Information.

Registrant Reference Number: 2018-130151

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

Address: 2920 Matheson Blvd. East

City: Mississauga

Prov / State: Ontario

Country: Canada

Postal Code: L4W 5J4

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

Human

4. Date registrant was first informed of the incident.

09-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

07-JUL-18

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.

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 product is an insect repellent, so the consumer sprayed it on herself, and accidentally sprayed the product in her eye.

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: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Pain
  • Symptom - Swollen eye

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

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

Eye

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 EYE SWELLING ("her eye is swollen") and EYE PAIN ("it is painful") in a female patient who received MUSKOL INSECT REPELLENT AEROSOL cutaneous spray. Other product or product use issues identified: ACCIDENTAL EXPOSURE TO PRODUCT "accidentally got Muskol spray in her eye" On 7-JUL-2018. On an unknown date, the patient started Muskol Insect Repellent Aerosol at an unspecified dose and frequency. On an unknown date, the patient experienced EYE SWELLING and EYE PAIN. At the time of the report, the EYE SWELLING and EYE PAIN had not resolved. The reporter provided no causality assessment for EYE PAIN and EYE SWELLING with Muskol Insect Repellent Aerosol.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.