BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ MODULITH SLX

    MDR report key: 372941 · Received January 15, 2002

    Report

    Report Number
    2020550-2001-00033
    Event Type
    Other
    Date Received
    January 15, 2002
    Date of Event
    December 12, 2001
    Report Date
    January 14, 2002
    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

    AFTER LITHOTRIPSY TREATMENT, IT WAS NOTED THAT PT HAD BEEN BURNED/BLISTERED AT THE TREATMENT SITE. THE STONE(S) WAS NOT FRAGMENTED COMPLETELY AND THE PT CAME BACK 2 DAYS LATER FOR URETERO LASER LITHOTRIPSY. THE BURN WAS HEALING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other