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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-5661

2. Registrant Information.

Registrant Reference Number: 197494

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: INDIANA

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. 4822-415

Product Name: OFF! Skintastic Family Formula Tropical Fresh 6 oz

  • Active Ingredient(s)
      • Guarantee/concentration 5 %

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: <=1 yr / < = 1 an

3. List all symptoms, using the selections below.


  • General
    • Symptom - Edema
  • Respiratory System
    • Symptom - Cyanosis
  • Blood
    • Symptom - Hypoxemia
    • Specify - hypoxia
  • Respiratory System
    • Symptom - Shortness of breath
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
    • Specify - lack of responsiveness

4. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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)


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?

>15 min <=2 hrs / >15 min <=2 h

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.)

On 6/11/2007, mother called to report that she had used product on her daughter 2 days prior and within 5 minutes of application, the child reportedly developed severe edema of the face, cyanosis, and lack of responsiveness. She was immediately taken to a local ER where she reportedly had an O2 saturation of 45%. In the ER, the child was treated with unspecified anti-inflammatory medications and antihistamines. She was also place on oxygen. Child rapidly recovered such that she was sent home within 3 hours of arrival. She was not sent home with any medications. It is important to note that this child is part of a triplet of children. The other two treated children did not suffering any complications. With this original report, the mother also alleged that An ER physician told her that this was the 3rd child under the age of 2 that they had seen in the past week suffering from what they believe is some kind of allergic reaction with an insect repellent.Follow-up was made on 6/13/2007 with the ER physician that treated this patient. He denies ever saying anything to the patient¿¿¿s mother about his seeing other cases involving severe reactions to OFF! insect repellents. The ER physician also states that he has not treated any other patients in the past with suspected reactions to OFF! insect repellents so he has no idea why the mother would make such a claim.This ER physician also mentioned that there were other items on the patient¿¿¿s differential diagnosis to explain the illness that she experienced and he did not make a definitive diagnosis that she suffered an allergic reaction to OFF! insect repellent. Apparently, other things had been applied to the child as well that day. The doctor did not elucidate on the other items in question, but did mention something about a sunscreen.

To be determined by Registrant

14. Severity classification.


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. The differential diagnosis for an apparent allergic of this nature would include multiple potential etiologies in addition to this product such as plant allergens, food, infectious pathogens, heat exposure, insect bites, etc. Skin patch testing would be required before labeling this product as the causative agent. The primary physician treating this patient did not make a definitive diagnosis of the the repellent being the causative agent and noted that there were other potential items to consider in this child's history. Also, given the inconsistency in the mother's account of events verses that of the treating physician, one has to question the credibility of the mother's history of events.