Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0924

2. Registrant Information.

Registrant Reference Number: 2997544

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.

02-JUL-21

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

01-JUL-21

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. 27325      PMRA Submission No.       EPA Registration No.

Product Name: OFF! FamilyCare Insect Repellent Tropical Fresh 175mL for kids 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

• Skin
  • Symptom - Erythema
  • Symptom - Irritated skin
  • Symptom - Itchy skin
  • Symptom - Rash
  • Symptom - Other
  • Specify - Burning sensation
  • Symptom - Red skin
  • Symptom - Burning skin

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

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?

<=15 min / <=15 min

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.)

7/2/2021 Caller purchased the product yesterday and sprayed it on herself, her 2 sons, her friend, and her friend's 1 year old daughter while at the beach. Immediately after applying it to her legs, caller started to have a burning sensation and redness. She applied more of the product on her legs than her arms and other areas. Consumer washed the product off for an unspecified amount of time and has been using Vitamin E oil to the affected areas. Today her legs are itching, red, and burning. She has less burning and redness on her arms. The skin on her legs is slightly raised with a rash. Her 2 sons are asymptomatic. Caller applied a small amount to her friend's leg yesterday to test the skin. Her friend reported some redness and burning immediately upon application. Caller did not specify if her friend's symptoms are remaining or if any treatments were performed. The 1 year old child has some redness and inflammation on her right arm and elbow crease. The product was sprayed all over her while at the beach yesterday, and her skin is still red and inflamed today. Caller did not specify if any treatments were performed. 7/5/2021 Call back to the original caller for follow up information. Her symptoms have improved somewhat, but still linger. She has not called her doctor. She has been applying aloe. She does not know how the other patients are doing.

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.

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

• Skin
  • Symptom - Erythema
  • Symptom - Irritated skin
  • Symptom - Red skin
  • Symptom - Burning skin

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

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?

<=15 min / <=15 min

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.)

7/2/2021 Caller purchased the product yesterday and sprayed it on herself, her 2 sons, her friend, and her friend's 1 year old daughter while at the beach. Immediately after applying it to her legs, caller started to have a burning sensation and redness. She applied more of the product on her legs than her arms and other areas. Consumer washed the product off for an unspecified amount of time and has been using Vitamin E oil to the affected areas. Today her legs are itching, red, and burning. She has less burning and redness on her arms. The skin on her legs is slightly raised with a rash. Her 2 sons are asymptomatic. Caller applied a small amount to her friend's leg yesterday to test the skin. Her friend reported some redness and burning immediately upon application. Caller did not specify if her friend's symptoms are remaining or if any treatments were performed. The 1 year old child has some redness and inflammation on her right arm and elbow crease. The product was sprayed all over her while at the beach yesterday, and her skin is still red and inflamed today. Caller did not specify if any treatments were performed. 7/5/2021 Call back to the original caller for follow up information. Her symptoms have improved somewhat, but still linger. She has not called her doctor. She has been applying aloe. She does not know how the other patients are doing.

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.

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: <=1 yr / < = 1 an

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Erythema
  • Symptom - Irritated skin
  • Symptom - Red skin
  • Symptom - Inflammation of the skin

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

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?

<=15 min / <=15 min

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.)

7/2/2021 Caller purchased the product yesterday and sprayed it on herself, her 2 sons, her friend, and her friend's 1 year old daughter while at the beach. Immediately after applying it to her legs, caller started to have a burning sensation and redness. She applied more of the product on her legs than her arms and other areas. Consumer washed the product off for an unspecified amount of time and has been using Vitamin E oil to the affected areas. Today her legs are itching, red, and burning. She has less burning and redness on her arms. The skin on her legs is slightly raised with a rash. Her 2 sons are asymptomatic. Caller applied a small amount to her friend's leg yesterday to test the skin. Her friend reported some redness and burning immediately upon application. Caller did not specify if her friend's symptoms are remaining or if any treatments were performed. The 1 year old child has some redness and inflammation on her right arm and elbow crease. The product was sprayed all over her while at the beach yesterday, and her skin is still red and inflamed today. Caller did not specify if any treatments were performed. 7/5/2021 Call back to the original caller for follow up information. Her symptoms have improved somewhat, but still linger. She has not called her doctor. She has been applying aloe. She does not know how the other patients are doing.

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.