BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIIG(R) X3 HI VISC

    MDR report key: 1804421 · Received August 17, 2010

    Report

    Report Number
    1043534-2010-00336
    Event Type
    Death
    Date Received
    August 17, 2010
    Date of Event
    August 8, 2010
    Report Date
    May 2, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    PMA / PMN Number
    K024336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT HAD AN OPERATION BECAUSE OF "VERTIBRAL COMPRESSIONS FRACTURES". THE BLOOD PRESSURE FELL DOWN SEVERAL TIMES, UNTIL CARDIAC ARREST. PATIENT WAS BROUGHT UP TO NORMAL LEVEL AND SENT TO ICU. ABOUT 12 HOURS LATER, THE PATIENT DIED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT HAD AN OPERATION BECAUSE OF "VERTEBRAL COMPRESSIONS FRACTURES". THE BLOOD PRESSURE FELL DOWN SEVERAL TIMES, UNTIL CARDIAC ARREST. PATIENT WAS BROUGHT UP TO NORMAL LEVEL AND SENT TO ICU. ABOUT 12 HOURS LATER, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIIG(R) X3 HI VISC BIOLOGIC COMPONENT MQV WRIGHT MEDICAL TECHNOLOGY, INC. 0701182541

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death