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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-5369

2. Registrant Information.

Registrant Reference Number: 1669706

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.

19-AUG-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

05-AUG-15

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. 28648      PMRA Submission No.       EPA Registration No.

Product Name: OFF! familycare Insect Repellant I smooth and dry 113g - 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?

No

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >6 <=12 yrs / > 6 < = 12 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Pneumonia

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

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.

Unknown / Inconnu

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.)

8/19/2015 Caller sprayed product on her son's skin approximately 2 weeks ago. Shortly after doing so, the child developed issues with breathing. She indicates that the child is being treated for pneumonia, however, she did not describe what type of treatment the child was receiving. The caller abruptly disconnected before further information could be obtained. On 8/20/2015 an attempt was made to contact the original caller. A message was left on voice mail requesting follow up information. 8/21/2015 Attempted call back to the original caller. A message was left requesting follow up information. The consumer has not since followed up to provide more information pertaining to her child's illness.

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. This product appears to be implicated in this case simply based on a temporal but coincidental product use scenario. The information made available by the reporter of this incident is sparse, thus eliminating the ability to develop any potential casual assessment. This was a misuse of the product since usage directions state DO NOT USE ON CHILDREN UNDER 12 YEARS OF AGE