Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4203

2. Registrant Information.

Registrant Reference Number: 521289

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-AUG-09

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

20-AUG-09

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. 23487      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Deep Woods for Sportsmen 1 Insect Repellent-230g Aerosol - Canada

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

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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.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Edema

• Respiratory System
  • Symptom - Shortness of breath

• Gastrointestinal System
  • Symptom - Tongue swelling

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.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 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.)

8/21/2009 Caller is a physician whose states that he treated a friend for what he believes may have been a severe allergic reaction. The OFF insect repellent had been used by the caller's friend on 8/20/2009 while spending time outdoors. Within 2-3 hours after application, the friend was bitten by a mosquito and then subsequently started to develop edema on her face and swelling of her tongue. The friend apparently reapplied the product resulting in a worsening of her symptoms. and the development of shortness of breath. The caller then treated the patient with an injection of adrenalin and Benadryl. The symptoms then abated within 12 hours. The friend is doing fine now. She was never seen at a medical facility. The friend has no history of allergic reactions to insect bites, and she has used this particular OFF product before with no adverse effects.

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 evaluating a patient for a potential allergic reaction such as Type I Hypersensitivity Reaction (anaphylaxis), a clinical practitioner must consider several potential environmental etiologies as well as any foods, beverages, medications, or dietary supplements the patient had been taking just prior to the onset of symptoms. Definitive causality cannot be applied to any one compound or agent without verification using specific and confirmatory allergy testing.