BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEALTH CARE PARTICULATE RESPIRATOR MASK

    MDR report key: 35622 · Received August 15, 1996

    Report

    Report Number
    MW1009720
    Event Type
    Other
    Date Received
    August 15, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 8, 1996
    Manufacturer
    3M CO.
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE'S CHEEKS, FOREHEAD, AND CHIN BECAME VERY HOT AND RED, WHILE BEING FIT-TESTED. REDNESS CONTINUED FOR SEVERAL HRS AFTER RESPIRATOR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTH CARE PARTICULATE RESPIRATOR MASK PARTICULATE RESPIRATOR MASK FXX 3M CO. * 073-6138033

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other