Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3835

2. Registrant Information.

Registrant Reference Number: 826749

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-11

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

16-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: OFF! Deep Woods (non-specific)

• 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.

Data Subject

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

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

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.)

7/26/2011 Caller states states she used the product for the first time 10 days ago. Within 4-6 hours she noticed a rash of red irritated bumpy skin that itched and burned on her arms and legs where she had sprayed the product. 1 day later the skin blistered all over the rash. Some blisters were very large. Caller went to doctor 2 days after application. Doctor prescribed hydrocortisone and antibiotic creams. Rash is now itchy scabs that are falling off. Her grandmother sprayed her arms the same day. She developed an identical rash and blisters on arms where the product was sprayed within the same time frame. She has not seen a doctor. Caller is at work without the product and is unable to provide product info or lot #. Follow-up received from consumer on 8/9/2011 in the form of a letter. The consumer provided copies of her medical records that included a physician's opinion that the patient experienced contact dermatitis from the insect repellent.

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 or allergic condition of this nature would include multiple potential etiologies which, in addition to this product, include such factors as plant allergens, insect bites, heat rash, mold, food, infectious pathogens, medications, dietary supplements, etc.. Target allergy testing would be required before labeling this product as the causative agent.

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 - Blister
  • Symptom - Erythema
  • Symptom - Irritated skin
  • Symptom - Itchy skin

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.

>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.)

7/26/2011 Caller states states she used the product for the first time 10 days ago. Within 4-6 hours she noticed a rash of red irritated bumpy skin that itched and burned on her arms and legs where she had sprayed the product. 1 day later the skin blistered all over the rash. Some blisters were very large. Caller went to doctor 2 days after application. Doctor prescribed hydrocortisone and antibiotic creams. Rash is now itchy scabs that are falling off. Her grandmother sprayed her arms the same day. She developed an identical rash and blisters on arms where the product was sprayed within the same time frame. She has not seen a doctor. Caller is at work without the product and is unable to provide product info or lot #. Follow-up on attempted on 8/1/2011, however the phone number provided by the consumer was not in service.

To be determined by Registrant

14. Severity classification.

Minor

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 or allergic condition of this nature would include multiple potential etiologies which, in addition to this product, include such factors as plant allergens, insect bites, heat rash, mold, food, infectious pathogens, medications, dietary supplements, etc.. Target allergy testing would be required before labeling this product as the causative agent.