Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1306

2. Registrant Information.

Registrant Reference Number: 1033708

Registrant Name (Full Legal Name no abbreviations): S.C. Johnson and Son, Limited

Address: 1 Webster Street

City: Brantford

Prov / State: ON

Country: Canada

Postal Code: N3T 5R1

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

Human

4. Date registrant was first informed of the incident.

31-AUG-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

31-JUL-12

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. 30211      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Clip-On Mosquito Repellent 46mg - Canada

• Active Ingredient(s)
  • METOFLUTHRIN

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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: Pub. Area - Outdoor/Zone publique - ext

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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.

Other

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Fainting

4. How long did the symptoms last?

<=30 min / <=30 min

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

Occupational

8. How did exposure occur? (Select all that apply)

Other

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

8/31/2012 Caller states that over a month ago while out to eat at a restaurant the personal mosquito repellent was used by a person nearby the patient. Apparently, after looking at the device attached to the person's belt, the patient 'blacked out' with a syncopal episode. An ambulance was called to the scene where paramedics found the patient awake with a normal EKG. As a precaution, the patient was transported to hospital for examination. A medical evaluation at the hospital ER consisting of an EKG, blood testing, MRI and Chest X-ray was unremarkable. The patient was not treated with any medications. Pt had a cardiac follow up with a specialist where he wore a heart monitor for 48 hours and that was also unremarkable. The cause of this syncopal episode remains a mystery.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed data, a causal relationship between the ingredient used in the mosquito repellent implicated in this case and the report of spontaneous syncope lacks any biological plausibility. The patient was not the one actually using the personal mosquito repellent.