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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1304

2. Registrant Information.

Registrant Reference Number: 1032307

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.

28-AUG-12

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

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)

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)
      • Unknown

7. b) Type of formulation.

Liquid

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

  • Cardiovascular System
    • Symptom - Cardiac arrest
  • General
    • Symptom - Malaise
  • Nervous and Muscular Systems
    • Symptom - Coma

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?

Yes

6. b) For how long?

3

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Application

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?

Unknown / Inconnu

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.)

8/28/2012 Caller states that he is a nudist and he goes out every day and sprays himself down with the product from head to toe. The caller states that he has been using the product every day since it came out about 20 years ago. The caller states that he bought the can that was a twin pack at Sam's Club, no receipt available. The day in question, he used a can that he believes had the wrong nozzle on it or it was malfunctioning, and it came out in a very large stream. Caller states this incident occurred on June 29th 2010. An unspecified period of time later, he started to feel ill and went to the hospital. While in the hospital he passed out and was "out" for 2.5 days during which time he was resuscitated twice. He was sent July 11th, to a rehab facility and was released July 16th. Caller was not able to elucidate on his medical care further. The caller alleges that laboratory testing suggested that he had DEET poisoning. He does not have the original container he had used in order to provide an EPA registration number. He just knows that it was a OFF! Deep Woods brand aerosol and that it contains DEET. Caller also states that he is still using the product daily even after this event as it is very effective. Caller just believes that this single instance was the problem. He does report having a history of blood clots, leg edema and water retention. He is currently taking Coumadin, Lipitor and Lasix.

To be determined by Registrant

14. Severity classification.

Major

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. When considering the body of regulatory data on DEET and post-marketing data collected over the past several years as well as the weight of scientific peer reviewed literature evidence of such a causal relationship in this case appears to be scientifically implausible. Even thought the product may have dispensed improperly on the skin, it would not be expected to product profound illness requiring hospitalization for several days. The fact that the patient continues to use the same brand of product after this medical event and is not encountering problems supports the safety of this particular product.