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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5513

2. Registrant Information.

Registrant Reference Number: 559372

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.

09-NOV-09

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

09-NOV-07

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.       PMRA Submission No.       EPA Registration No. 4822-415

Product Name: (discontinued) OFF! Skintastic for Kids USA (Pump Spray) 6 oz

  • Active Ingredient(s)
    • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO + PARA ISOMERS)
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

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: Male

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Taste altered
  • Cardiovascular System
    • Symptom - Stroke
  • Nervous and Muscular Systems
    • Symptom - Dizziness
    • Symptom - Numbness
    • Symptom - Paresis
    • Specify - Right sided hemiparesis

4. How long did the symptoms last?

>6 mos / > 6 mois

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

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

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.)

11/9/2009 Caller reports that he applied two light pumps of the product to the back of his head 2 years ago because of gnats in the office. Within seconds of application, caller reports that he had a major stroke where he lost the use of his right hand and he right side of his body went numb. Caller also reports losing the ability to taste most food. He was hospitalized on the day his symptoms began, however, the caller was unable to relate how long his hospitalization lasted. Caller has been under the care of a neurologist and has been undergoing rehabilitation. Caller has a history of Lyme's disease. He states that he continues to feel the after effects of this stroke.

To be determined by Registrant

14. Severity classification.

Major

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 signs and symptoms reported in this case are not consistent with the known toxicology profile of the product involved when it has been used in the manner described. The weight of medical and scientific data on DEET containing insect repellents found in the peer reviewed scientific literature does not remotely support the notion that profound toxicity such focalized cerebrovascular disease following very light repellent use is biologically plausible. Secondly, one of the hallmark features of toxicologically induced systemic neurological injury is that the clinical effects are bilateral in nature, rather than unilateral as presented in this case.