BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOLI S

    MDR report key: 326968 · Received April 11, 2001

    Report

    Report Number
    MW1021616
    Event Type
    Injury
    Date Received
    April 11, 2001
    Report Date
    March 30, 2001
    Manufacturer
    DORNIER MEDICAL SYSTEMS, INC.
    Product Code
    NCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A TOTAL OF 36 PTS WERE EVALUATED WITH ULTRASOUND BEFORE AND AFTER ESWL WITH THE DOLI S MACHINE. SUBCAPSULAR HEMATOMA RESULTED IN 4 KIDNEYS OF 4 PTS FOR AN INCIDENCE OF 15%. FINDINGS OF 15% OCCURRENCE OF PERIRENAL HEMATOMA IS ABOVE THE ACCEPTED 0.2-0.4% COMMONLY NOTED WITH OTHER LITHOTRIPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16473 DOLI S LITHOTRIPTER NCV DORNIER MEDICAL SYSTEMS, INC. DOLI S *

    Patients

    Seq Age Sex Outcome Treatment
    1 *