Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-5105

2. Registrant Information.

Registrant Reference Number: 1006834

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.

13-JUL-12

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

29-JUN-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: Personal use / Usage personnel

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.

Data Subject

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Nausea

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Itchy skin

• Nervous and Muscular Systems
  • Symptom - Sleepiness
  • Specify - extremely tired
  • Symptom - Muscle weakness
  • Specify - unable to move leg
  • Symptom - Difficulty walking

4. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

Yes

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.

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

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.)

July 13, 2012 Caller used the product in the evening on 6/29/12 while camping. Caller estimates that she used the product for 5 min total, 2-3 min then turned the product off then used for another 2-3 min. The caller woke up at approx 4am (6-8 hours after use) due to extreme itching on the palms of her hands and soles of her feet. Caller states that shortly after she woke up she was extremely tired and went back to sleep for a short period of time. When she woke back up she felt nauseous and had some diarrhea. The caller tried to walk to the car but found that she was unable to move her legs. The caller was carried to the car and taken to an emergency room. Several tests were done including EKG monitoring, unspecified bloodwork and CT scan. All tests came back normal. The caller was observed for a few hours in the ER and treated with an unspecified medication. Caller states that the intense itching resolved approx 1 hour after arriving at the hospital. Caller states that she was asx within 24 hours of initial exposure.

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. The reported signs and symptoms are not consistent with the known toxicological profile of the active ingredient used in this product. Several potential etiologies must be considered when developing a differential diagnosis for this patient's ailment. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredient used in this product a definitive causal relationship cannot be established.