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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6741

2. Registrant Information.

Registrant Reference Number: 3651890

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.

05-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

03-JUL-23

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: OFF! Deep Woods - non-specific

  • 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

  • Blood
    • Symptom - Bleeding
  • Skin
    • Symptom - Blister
    • Symptom - Erythema
    • Symptom - Irritated skin
    • Symptom - Itchy skin
    • Symptom - Rash
    • Symptom - Other
    • Specify - Skin warm

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.

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

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.)

7/5/2023 Caller reports that she has purchased other OFF!! products a few times and used them without issue. When she bought the 3 pack of this product, she applied it to herself only one time on 7/2/2023. Shortly afterwards, she noticed that her arms, neck, and parts of her face were looking red and felt warm and irritated. She has been washing and using topical soothers and creams, but nothing seems to be helping. She already threw it away so had only the name and no specific product information. She feels there is something wrong with the product. Caller seems convinced that there must be something wrong with this product. 7/10/2023 Callback was attempted but call was not answered and never went to voicemail. Unable to speak to the caller or to leave her a message. 7/10/2023 Caller, consumer's son, calling back. He reports that consumer experienced itchy warm-to-touch rash on legs and arms starting at elbows and below. The rash on both arms turned into blisters. Caller would scratch affected areas until experiencing bleeding. Caller states that consumer was working in yard and applied product to both arms and legs on 07/02/2023 to keep insects away. Caller clarifies she did not experience any symptoms on 07/02/2023 from use of product. Caller states the next morning consumer noticed symptoms described above. Caller states consumer called who she thought was customer service on 07/03/2023, and was instructed to apply baking soda, vinegar, and lemon mixture to rash. Consumer applied mixture to rash on arms and legs daily. The rash on the legs improved and resolved within an undisclosed amount of time. The rash on the arms progressively got worse and turned into blisters by 07/07/2023, and the blisters burst the next day, 07/08/2023. Caller states that the open blisters were still itching causing consumer to scratch until she noticed some blood. Consumer continued to apply mixture of baking soda, lemon, and vinegar to both arms. Caller states that consumer purchased over-the-counter Claritin on 07/10/2023 and took one. Caller states that consumer was still experiencing itching of open blisters today after taking Claritin. Consumer has been using product for several years experiencing no reaction, until purchasing this bottle from Costco about 1 month ago. 7/11/2023 Attempted callback and spoke with caller. His mom is currently at work, and he has not spoken with her. She has not had time to be seen. He will check in on her and asked to be called back at the end of the week. 7/14/2023 Attempted CB: Call range twice and disconnected. Unable to leave a voicemail message. No further information is available.

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.