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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-5841

2. Registrant Information.

Registrant Reference Number: 2097328

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.

22-AUG-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 24723      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Deep Woods 3 Insect Repellent 230g - 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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Shortness of breath
  • Skin
    • Symptom - Hives
    • Symptom - Itchy skin
    • Symptom - Discolouration
    • Specify - Skin discoloration

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?

Yes

6. b) For how long?

2

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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?

>1 wk <=1 mo / > 1 sem < = 1 mois

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.)

8/22/2017 Caller applied this product to her legs on 8/12/2017. Approximately 15 minutes later, her legs started to itch. She then got into the shower to wash the product off. After her shower, her legs and back started to turn purple. During the morning of 8/13/2017 she woke up with difficulty breathing and hives on her legs and back. Her mother drove her to the emergency room. At the emergency room, she was given intravenous fluids with Morphine, Benadryl, and Penicillin. She was also given oral Benadryl. She stated her condition did not improve in the hospital. Her doctor diagnosed her with an allergic reaction to the product. She was admitted to the hospital. No further treatments were performed. She was observed until her discharge during the evening of 8/15/2017. No prescriptions were given. Caller had a follow up with her primary care doctor today, 8/22/2017. No treatments were performed and no prescriptions were given. Her doctor told her just to monitor herself. She states she is still itching and still has the skin discoloration. Caller has allergies to lactose, pollen and grass. Caller also has Celiac disease. 8/24/2017 Call back to the original caller for follow up. Caller states that itching and discoloration is still present. She has not had any other treatments, and has a follow up scheduled with her doctor.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The differential diagnosis for a skin or allergic condition of this nature includes multiple potential etiologies which, in addition to this product include such factors as plant allergens, poison ivy, poison oak, food, medications, dietary supplements, household soaps, skin care products, infectious pathogens, heat exposure, insect bites, etc. Targeted allergy testing would be required before concluding that this product may be the causative agent. 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.