Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1712

2. Registrant Information.

Registrant Reference Number: 2491441

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.

30-JUL-19

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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)

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PMRA Registration No. 28648      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Familycare Insect Repellent Smooth & Dry

• 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

• General
  • Symptom - Edema

• Skin
  • Symptom - Blister
  • Symptom - Erythema
  • Symptom - Irritated skin

4. How long did the symptoms last?

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

5. Was medical treatment provided? Provide details in question 13.

No

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

7/30/2019 Consumer sent an email stating that she applied the product and felt pain on the back of her knee. She applied several cold water compresses, and later that evening noticed swelling. It was 3 weeks ago, and it is now starting to feel better. 7/31/2019 Attempted to call consumer, but was unable to reach consumer or leave a message. 8/1/2019 An email was sent to consumer requesting follow up. 10/2/2019 Consumer is calling back. She used the product in July 2019. On the third day of use she developed irritation, redness, swelling, and blisters. She returned from vacation on the third day, and saw a local pharmacist who advised using Filamazine cream for 10 days. She states that after using the cream for 10 days the signs resolved.

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.