Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4049

2. Registrant Information.

Registrant Reference Number: 2464398

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.

19-JUN-19

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

19-JUN-19

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. 23487      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Deep Woods For Sportsmen1 Insect Repellent, 230g [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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Edema

• Nervous and Muscular Systems
  • Symptom - Slight paralysis
  • Symptom - Numbness

• Eye
  • Symptom - Other
  • Specify - droopy eye

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?

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?

>8 hrs <= 24 hrs / >8 h <= 24 h

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

6/19/2019 Caller sprayed the product on her hand and then applied it to her forehead and neck yesterday before a walk. Caller took a shower last night after her walk. This morning she is experiencing left side eye droop and the left side of her face doesn't feel right. There is swelling on the left side of her face. Caller spoke with her medical provider and was advised that she needs to go to the emergency room. 6/20/2019 Attempted call back to the original caller. A message was left requesting follow up information. 6/21/2019 Caller did go to the emergency room, and was there for 3 hours. They did a stroke evaluation, and saw no signs of a stroke. No further testing was done and she was given no treatments. She did inform them about the use of the product. They did not have an opinion as to whether the symptoms had anything to do with the product. Her face is still swollen around her left eye and cheek, and she still has some numbness. Her eye is still droopy. 6/26/2019 Caller did see her doctor yesterday. The doctor thinks it was the product that caused the symptoms. She will be having a computer tomography scan. Her eye lid is almost back to normal, but she is still experiencing numbness around her mouth. The swelling has mostly resolved. 7/10/2019 Attempted call back to the original caller. A message was left requesting follow up information. 7/11/2019 Attempted call back to the original caller. A message was left requesting follow up information. Caller is returning the previous message. Caller had a computer tomography scan last night, and the results should be sent to her doctor within 2 to 3 days. She still has some numbness on the left side. 7/25/2019 Caller is much improved, but still has numbness around her mouth. The computer tomography scan was normal.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The signs and symptoms reported in this case are not consistent with the known toxicology profile of the product involved when it has been used in the manner described. 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.