BEUDAMED
    FDA Adverse Event Other Summary report: N

    STORZ MODULITH

    MDR report key: 484296 · Received September 15, 2003

    Report

    Report Number
    1061158-2003-00020
    Event Type
    Other
    Date Received
    September 15, 2003
    Date of Event
    July 16, 2003
    Report Date
    September 10, 2003
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LNS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OBESE PT WAS TREATED WITH ESWL FOR LEFT URETER STONE AND WAS PLACED IN AN EXTREME OBLIQUE POSITION. AFTER 4500 SHOCKWAVES TREATMENT, A ROUND SHAPED BLISTER, BURN-LIKE SORE WAS NOTED ON THEIR LEFT FLANK AREA. THIS APPEARED IN THE SHAPE OF A COIL. PT'S BLISTER WAS TREATED AND FULL RECOVERY IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ MODULITH ESWL LNS STORZ MEDICAL AG SLX *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other