BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1100943 · Received May 6, 2008

    Report

    Report Number
    2020550-2008-00009
    Event Type
    Other
    Date Received
    May 6, 2008
    Date of Event
    February 9, 2007
    Report Date
    May 6, 2008
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LNS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES THAT AFTER UNDERGOING A KIDNEY STONE FRAGMENTATION PROCEDURE, HE EXPERIENCED RINGING IN HIS EARS. HE INITIALLY REPORTED THIS TO US BY LETTER REC'D ON 03/10/08, BUT THERE WAS NOT ENOUGH INFO TO CONFIRM KARL STORZ PRODUCT WAS INVOLVED. HE CALLED BACK ON 04/18/08 AND CONFIRMED SLX-F2 INVOLVED. THUS, WE ARE BASING OUR REPORTING PARAMETERS ON THE LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LITHOTRIPTOR LNS STORZ MEDICAL AG SLX-F2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other