Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4115

2. Registrant Information.

Registrant Reference Number: 3301001

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.

16-JUN-22

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. 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)

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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: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Nausea
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Dizziness

• Respiratory System
  • Symptom - Other
  • Specify - Nasal infection
  • Symptom - Other
  • Specify - Throat infection

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.

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

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

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.)

6/16/2022 Caller and a friend applied product on their vests on an unspecified date. Caller has experienced nausea, dizziness, and vomiting since the exposure. Caller called a medical clinic and was advised to drink plenty of water and milk which he has done. His friend experienced dizziness, and his friend does not wish to give any other information. The call disconnected. An attempt was made to call the consumer back, and a voice message was left requesting follow up. The original caller is calling back. Caller and his friend applied the product on their vests, hats, and hands prior to entering the woods on 6/14/2022. They have both been experiencing nausea, vomiting, and dizziness. They called a poison control center and were advised to drink plenty of milk and water, but when caller does this he vomits. Caller's friend is doing much better, and actually only had some nausea. Caller and his friend both washed the product off of their hands the same day it was applied. 6/21/2022 Call back to the original caller for follow up. He was seen by his doctor and blood work was done. He says the product wasn't in his blood. He was diagnosed with a nasal infection and a throat infection caused by the product on his clothing. He was told not to use it again. He was prescribed something unknown to rinse his nasal passages, and an unknown oral medication to take twice per day. His friend is good, and it did not affect him as much. 6/29/2022 Call back from the original caller. He went to the doctor and was prescribed medication. For the past 2 days he has been asymptomatic.

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.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Nausea

4. How long did the symptoms last?

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

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

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

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.)

6/16/2022 Caller and a friend applied product on their vests on an unspecified date. Caller has experienced nausea, dizziness, and vomiting since the exposure. Caller called a medical clinic and was advised to drink plenty of water and milk which he has done. His friend experienced dizziness, and his friend does not wish to give any other information. The call disconnected. An attempt was made to call the consumer back, and a voice message was left requesting follow up. The original caller is calling back. Caller and his friend applied the product on their vests, hats, and hands prior to entering the woods on 6/14/2022. They have both been experiencing nausea, vomiting, and dizziness. They called a poison control center and were advised to drink plenty of milk and water, but when caller does this he vomits. Caller's friend is doing much better, and actually only had some nausea. Caller and his friend both washed the product off of their hands the same day it was applied. 6/21/2022 Call back to the original caller for follow up. He was seen by his doctor and blood work was done. He says the product wasn't in his blood. He was diagnosed with a nasal infection and a throat infection caused by the product on his clothing. He was told not to use it again. He was prescribed something unknown to rinse his nasal passages, and an unknown oral medication to take twice per day. His friend is good, and it did not affect him as much. 6/29/2022 Call back from the original caller. He went to the doctor and was prescribed medication. For the past 2 days he has been asymptomatic.

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.