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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3834

2. Registrant Information.

Registrant Reference Number: 823859

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.

21-JUL-11

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

14-JUL-11

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. 22258      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Deep Woods Pump Spray Insect Repellent 100 mL - Canada

  • 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).

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Eye
    • Symptom - Blurred vision
    • Symptom - Double vision

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?

<=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.)

7/21/2011 Caller states that on July 14 her husband closed his eyes and sprayed his face with the OFF! product. When they went for a walk he started experiencing double vision. He did shower afterwards. By Monday July 18 his symptom worsened. He went to a local ER were unspecified scanning techniques were not able to find a cause. He was told by a physician that his eye muscles have weakened somehow. This patient does have a history of blood clots and is taking coumadin. Follow-up on 8/4/2011 The wife reports that her husband is still having problems with his vision but there is improvement. He also has some blurred vision. The doctor feels that the symptoms will gradually subside. A head CT scan was unremarkable and ruled out a blood clotting problem.

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. With direct eye exposure to this insect repellent, the typical clinical manifestations of such an exposure are eye irritation and possibly conjuctivitis. These symptoms were not reported in this case. The disorder as reported is not typically associated with direct spray of the repellent in the face and eyes.