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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4505

2. Registrant Information.

Registrant Reference Number: 527804

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.

03-SEP-09

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

03-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)

PMRA Registration No. 27324      PMRA Submission No.       EPA Registration No. 4822-395

Product Name: OFF!Skintastic Spray Insect Repellant Family Summer Splash175mL-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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Irritated skin
    • Symptom - Itchy skin
    • Symptom - Rash

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)

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.)

9/3/2009 Caller applied the product to her neck and arms one month ago. Within 10 minutes caller developed irritation at the application sites, and caller washed with soap and water. Caller developed an itching rash in the areas, and has seen her doctor twice for treatment. The doctor prescribed hydrocortisone cream both times which helped with the itching, but the symptoms are still persisting. She did not use sunscreen or any other products with this repellent. She has no known allergies 9/9/2009 Callback attempted to the original caller. A message was left requesting follow up information. 9/10/2009 Callback attempted to the original caller. A message was left requesting follow up information. No information was received from the consumer as of Oct 14, 2009.

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 differential diagnosis for a skin condition of this nature would include multiple potential etiologies which, in addition to this product, include such factors as plant allergens, poison ivy, poison oak, food, infectious pathogens, heat exposure, insect bites, etc. Skin patch testing would be required before labeling this product as the causative agent.