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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3686

2. Registrant Information.

Registrant Reference Number: 1-26619448 A

Registrant Name (Full Legal Name no abbreviations): Watkins Incorporated

Address: 277 Hutchings Street

City: Winnipeg

Prov / State: MB

Country: Canada

Postal Code: R2X 2R4

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

27-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-JUN-11

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. 29970      PMRA Submission No.       EPA Registration No.

Product Name: Watkins Great Outdoors Insect Repellent Spray

  • Active Ingredient(s)
    • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES

PMRA Registration No. 14326      PMRA Submission No.       EPA Registration No.

Product Name: Watkins Great Outdoors Insect Repellent Lotion

  • 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).

Individual (mother) reporting advised that she applied Spray to (age) year old daughter. Daughter's face became red, swollen and claimed to be having trouble swallowing. Mother was advised to discontinue use immediately and consult with a physician. Did not indicate quantity or location of application. In a follow-up call to mother, we were advised physician suggested patient to take Benadryl and has since recovered.

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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Erythema
    • Symptom - Edema
    • Symptom - Irritated skin
  • Gastrointestinal System
    • Symptom - Difficulty swallowing
  • Skin
    • Symptom - Rash

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

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)

Unknown

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.)

1-26619448- The reporter, a parent, indicates she child was exposed to an insect repellant containing the active ingredient DEET. The reporter indicated she applied the product to the skin of her (age) year old daughter one and two days prior to the initial contact with the registrant. She reports the day prior to her initial contact with the registrant she noted her daughter¿s skin on her face was red. Just prior to her initial contact she noted the child¿s throat was swollen and she was having difficulty swallowing and her throat was sore. The reporter was advised to seek medical attention for the apparent allergic reaction. On follow up the reporter indicated the child was improved. She was brought to a physician and was advised to take Benadryl every 4-6 hours. The patent was advised by the physician to avoid the use of products with the active ingredient DEET in the child in the future. No diagnosis was offered by the caller. No further information is available.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.