BEUDAMED
    FDA Adverse Event Death Summary report: N

    LITHOGOLD

    MDR report key: 1702632 · Received May 18, 2010

    Report

    Report Number
    3005462245-2010-00001
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    July 5, 2007
    Report Date
    February 4, 2010
    Manufacturer
    MTS EUROPE GMBH
    Product Code
    LNS
    PMA / PMN Number
    K062081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SERVICE TECH RECEIVED INFO THAT THE PT FOR RENAL LITHOTRIPSY SUFFERED A PERIRENAL HAEMATOMA POST TREATMENT. PT WAS DISCHARGED POST TREATMENT AND EXPIRED APPROX 4 DAYS POST TREATMENT. THE FAMILY ALLEGEDLY DECLINED AN AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOGOLD LITHOGOLD LNS MTS EUROPE GMBH LG380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death