BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIOUS

    MDR report key: 888628 · Received July 29, 2007

    Report

    Report Number
    MW5003221
    Event Type
    Injury
    Date Received
    July 29, 2007
    Date of Event
    July 28, 2007
    Report Date
    July 29, 2007
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    SELF-TESTING OF A HIGH GRADE SURGICAL FACEMASK AND A HIGH GRADE CONSUMER FACEMASK USING A HAZARDOUS GAS METER MADE BY INDUSTRIAL SCIENTIFIC 2007 AND AGAIN EIGHT DAYS LATER, I DISCOVERED THAT DANGEROUS LOW OXYGEN LEVELS ARE IMMEDIATE AND CONSISTENT. THIS FINDING WAS IMMEDIATE AND PERSISTENT. IT APPEARS THAT ALL TIE ON, EAR LOOP, ELASTIC BAND FIBER FACEMASKS ARE DANGEROUSLY DEFECTIVE TO THE WEARER BECAUSE THEY CREATE A LOW OXYGEN ENVIRONMENT FOR THE WEARER. THESE PRODUCTS AFFECT A VERY LARGE SEGMENT OF THE POPULATION. USAGE CAUSES AN IMMEDIATE DROP OF OXYGEN TO UNSAFE LEVELS. LOW OXYGEN LEVEL IMPAIRMENT IS PROBABLE. DOSE OR AMOUNT: LOW O2 -BELOW 19.5%- HIGH CO2 -ABOVE. FREQUENCY: 36-40 HRS / WK. ROUTE: INHALE. DATES OF USE: 1985 - 2007 +27 YEARS. DIAGNOSIS OR REASON FOR USE: SAFETY DEVICE COMMONLY USED. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIOUS SURGICAL AND CONSUMER FACEMASKS FXX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability