BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGEN REGULATOR

    MDR report key: 1852904 · Received September 28, 2010

    Report

    Report Number
    MW5017632
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MADA MEDICAL
    Product Code
    CAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ATTACHED A REGULATOR TO AN OXYGEN CYLINDER. WHEN SHE OPENED THE VALVE, FLAMES CAME UP AND BURNED THE PT'S HAND. DIAGNOSIS OR REASON FOR USE: COPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN REGULATOR OXYGEN REGULATOR CAN MADA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR