BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1475825 · Received September 16, 2009

    Report

    Report Number
    MW5012741
    Event Type
    Malfunction
    Date Received
    September 16, 2009
    Date of Event
    February 12, 2008
    Report Date
    February 16, 2009
    Manufacturer
    *
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT SHE HAD A PROCEDURE DONE IN 2008, IN WHICH AN NDO PLICATOR DEVICE WAS USED. SHE SAYS THAT SINCE THAT PROCEDURE, SHE HAS HAD EPIGASTRIC PAIN AND TIGHTNESS, IF SHE IS ON HER FEET FOR A COUPLE OF HOURS SHE BEGINS TO HAVE SEVERE ABDOMINAL PAIN, CHEST PAIN, AND NAUSEA AND HAS TO LIE DOWN. REPORTER ALSO SAYS SHE IS UNCOMFORTABLE WHEN SITTING DOWN. REPORTER SAYS SHE WAS ONLY SUPPOSED TO BE OUT OF WORK FOR 4 WEEKS, BUT SHE HAS NOT BEEN ABLE TO WORK FOR 5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * NDO PLICATOR ODE * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR