Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5589

2. Registrant Information.

Registrant Reference Number: 2738354

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.

10-AUG-20

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)

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PMRA Registration No. 24723      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Deep Woods 3 Insect Repellent, 311g [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.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Nausea

• Cardiovascular System
  • Symptom - Hypotension

• Nervous and Muscular Systems
  • Symptom - Muscle weakness

• Respiratory System
  • Symptom - Shortness of breath

• Skin
  • Symptom - Tingling skin

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)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

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.)

8/10/2020 Caller's sister started using the product approximately 5 weeks ago. She applied the product all over while on her porch prior to leaving for a walk. She stated to experience shortness of breath, low blood pressure, nausea, weakness, and tingling in her limbs. She is unable to identify when she started to have the symptoms. She went to the hospital on 7/21/2020. The hospital put her on a heart monitor, performed blood tests, and also performed another unknown test. All of the tests came back normal. They thought the symptoms may be related to anxiety, and prescribed a medication for her to take for anxiety. She went home and continued to have the symptoms. She went back to the emergency room on 8/3/2020. They found that she had a urinary tract infection, and prescribed antibiotics for treatment. The last time she used the product was on 7/26/2020. She is continuing to have the symptoms, and they appear to be worsening.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The relationship between the use of a DEET containing product and the development of the complications reported in this case is unexpected and lacks biological plausibility. The differential diagnosis for a condition of this nature includes multiple potential etiologies. Targeted testing would be required before concluding that the product was 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.