Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3225

2. Registrant Information.

Registrant Reference Number: 352453

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.

26-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

19-JUL-08

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.       PMRA Submission No.       EPA Registration No. 4822-399

Product Name: OFF! Deep Woods Sportsmen Insect Repellent III Pump Spray - 6 oz. - US

• Active Ingredient(s)
  • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO + PARA ISOMERS)
    • Guarantee/concentration 25 %

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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.

Other

2. Demographic information of data subject

Sex: Male

Age: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Other
  • Specify - Myocardial disease NOS
  • Symptom - Chest pain
  • Symptom - Tachycardia

• Gastrointestinal System
  • Symptom - Nausea

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Muscle weakness

• Respiratory System
  • Symptom - Shortness of breath

• Nervous and Muscular Systems
  • Symptom - Unconsciousness
  • Symptom - Stiffness

4. How long did the symptoms last?

Unknown / Inconnu

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.

Skin

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.)

7/26/2008 The caller's son reportedly used the product as directed on 7/19/08. Product was applied on his clothes and body before he went fishing fishing. Later that day while he was standing in a river fishing, he lost consciousness and fell into the river. He was rushed to a local ER where they performed some unspecified tests and sent him home on unspecified medications. The patient then had another episode of on 7/22/08 where he was unable to move and his body was stiff. He was again rushed to a local ER, where the caller states the MD suggested that this may have been connected to the DEET in the repellent. The caller states that her son suffered from some type of unspecified cardiac muscle damage. The patient was not admitted to the hospital but was sent home with anti-anxiety medications and pain medications. The caller states that her son is still experiencing nausea, chest pain, weakness, and shortness of breath. 7/28/2008 Follow-up with patient¿s mother. She confirmed that her son was never actually admitted to the hospital. He has been to the ER twice over the past week for his recurring symptoms. She was only able to relate that she was told that her son's heart muscle is damaged somehow. The mother could not remember the actual medical term that described her son's heart problem. She relates that her son has used insect repellents on multiple occasions during his lifetime, typically when he goes fishing like he did on 7/19.

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 repellent 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 support the notion that profound toxicity such as cardiomyopathy following routine repellent use is biologically plausible.