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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1068

2. Registrant Information.

Registrant Reference Number: X

Registrant Name (Full Legal Name no abbreviations): X

Address: X

City: X

Prov / State: X

Country: X

Postal Code: X

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

Human

4. Date registrant was first informed of the incident.

23-MAR-09

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

12-FEB-09

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.

Product Name: CUTTER SKINSATIONS INSECT REPELLENT

  • 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).

I bought some Cutter Skinsations Insect Repellent (Ident. #17-10579), and applied it liberally to my arms and all of the bite sites that night. I did this without reading the instructions on the bottle, and accept, without reservation, full consequences for my actions.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

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

  • Eye
    • Symptom - Blurred vision
  • Nervous and Muscular Systems
    • Symptom - Dizziness
    • Specify - Vertigo

4. How long did the symptoms last?

<=30 min / <=30 min

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

Yes

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

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.)

While camping recently in [state], I received about 20-30 insect bites on my arms one night from what I believe were no-see-ums. I had a fairly strong reaction to the bites, with significant swelling at each bite, and very itchy. The next day I bought some Cutter Skinsations Insect Repellent (Ident. #17-10579), and applied it liberally to my arms and all of the bite sites that night. I did this without reading the instructions on the bottle, and accept, without reservation, full consequences for my actions. The following day, I experienced about a 30 second period of blurred vision and vertigo. I went to the [name] Medical Centre to get checked out. The doctor I saw thought it could have been a small stroke, but also thought it might have been due to the improper use of the insect repellent. (The product label says do not apply over cuts, wounds or infected skin, and to apply sparingly.) In order to develop the best possible understanding of my current health, I would appreciate your advice as to whether or not the symptoms I experienced could have been caused by my improper use of this product? Went to (name) Medical Centre, (location) on February 12, 2009. They checked my vitals, did blood and urine analysis, CAT Scan, EKG, etc... Prescribed one mild strenght aspirin per day.

To be determined by Registrant

14. Severity classification.

15. Provide supplemental information here.