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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3061

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.

22-JUN-10

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

07-JUN-10

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. 2009-4716      EPA Registration No.

Product Name: Norwex Mattress Cleaner

  • Active Ingredient(s)
    • AMYLASE
    • CELLULOSE (FROM POWDERED CORN COBS)
    • PROTEASE ENZYME

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

8

Other Units: squirts

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

Préciser le type: On Mattress

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

The aerosol is sprayed on to a mattress from the bottle it was sold, probably 8 squirts from the bottle. Unsure as to the exact amount. I phoned (Norwex) but they haven't returned my call.

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Sinus pain
  • General
    • Symptom - Swelling
    • Specify - forehead
  • Eye
    • Symptom - Swollen eye
  • General
    • Symptom - Swelling
    • Specify - Sinus

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Unknown

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)

Contact with treated area

What was the activity? slept on mattress, entered sprayed roomat time of 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

Eye

Oral

Respiratory

11. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

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.)

Unsure as to product registration. Norwex Mattress Cleaner. Suspected active ingredient: cocamidopropyl betaine (American Dermatology 2004 allergen of the year). I had a sunburn and used vinegar and aloevera for the burn as I had previously without issure to help the skin. Concurrent to that my mother sprayed Norwex Mattress Cleaner on the mattress, that I breathed and had to slept on. My sinuses, eye and forehead had swelling and the part I slept on was most painful. As I woke up with swelling in the mornings which I did from 1 bed. My sinuses were swollen for approximately 5 days. I walked into the room when the spray was being used and inhale it. Also, I slept in the bed for a couple nights before changing to a different bed, then the swelling went down after changing rooms, bedsheets, mattress. Anyways, I believe the sunburn & the Norwex Mattress Cleaner worked together to give me severe sinus inflamation and the second day my eye was more inflammed as I was sleeping with it down in the mattress, perhaps the microbes in the spray infected my eyes. The spray also has cocamidopropyl betaine (named 2004 allergen of the year by the American Dermatology Association (i.e. Wikipedia) The Norwex Mattress Spray doesn't put this on the bottle. The most concerning thing to me is that my mother uses this spray. She had sinus cancer and had her sinuses removed. There are a few cases of this as cancer as the (name) hospital 'reports'. My sinuses were severely swollen and this worries me as to the possible carcinogenic nature of this product; I don't believe my sinuses/eye would have swollen up w/ my aloe/vera or vinegar treatment of the sunburn alone. Also, I was dissapointed about the 'lack of labelling' on the Norway product, given the extreme allergen in the bottle. Norwex, I phoned but they haven't returned my call.

To be determined by Registrant

14. Severity classification.

15. Provide supplemental information here.