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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6141

2. Registrant Information.

Registrant Reference Number: 2272874

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.


4. Date registrant was first informed of the incident.


5. Location of incident.


Prov / State: MICHIGAN

6. Date incident was first observed.


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.


PMRA Registration No.       PMRA Submission No.       EPA Registration No. 4822-167

Product Name: OFF! Deep Woods Insect Repellent V 6oz

  • Active Ingredient(s)
      • Guarantee/concentration 25 %

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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?


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.


  • Blood
    • Symptom - Coagulopathy
  • General
    • Symptom - Edema
  • Skin
    • Symptom - Erythema
    • Symptom - Irritated skin
    • Symptom - Itchy skin
    • Symptom - Other
    • Specify - Cellulitis

4. How long did the symptoms last?

Unknown / Inconnu

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


6. a) Was the person hospitalized?


6. b) For how long?


7. Exposure scenario


8. How did exposure occur? (Select all that apply)


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)


10. Route(s) of exposure.


11. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

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.)

7/17/2018 Caller applied the product to her lower legs on 7/11/2018 while camping. The next day, she noticed that her legs had dermal irritation, redness, swelling, and were warm to the touch. She washed her legs when she noticed the symptoms. 7/24/2018 Call back to the original caller for follow up. Caller was seen at her primary physician's office on 7/18/2018 where she was advised to go to the emergency room. She had an ultrasound completed on one leg which showed a blood clot. She was prescribed Keflex for cellulitis and started on Eliquis for the blood clot. She told the doctor about product use, and the doctor did not feel her symptoms were related to product use. Blood work was performed at the emergency room, but she is unaware of the results. Her legs are painful and stinging today. She has been elevating her legs at home and using warm and cold compresses. She has a follow up appointment with her physician on 7/26/2018. She has itching from the knee down to the top of her foot. She has been taking Hydroxyzine that was a previously prescribed medication. 7/27/2018 Call back to the original caller for follow up. Caller saw her doctor yesterday, and was told that the product did not have anything to do with her symptoms. She was put on Eliquis to prevent blood clots and Lasix to reduce the swelling in her legs. The doctor said she does not have cellulitis.

To be determined by Registrant

14. Severity classification.


15. Provide supplemental information here.

Any relationship between the use of this product and the delayed development of the complications reported in this case is inconceivable and lacks biological plausibility. The differential diagnosis for a skin or allergic condition of this nature includes multiple potential etiologies. Targeted allergy testing would be required before concluding that this product may be the causative agent. Additionally a physician who examined here stated that there was no relationship tween her use of the product and the symptoms noted. 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.