BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 619183 · Received June 21, 2005

    Report

    Report Number
    2020550-2005-00011
    Event Type
    Other
    Date Received
    June 21, 2005
    Date of Event
    April 22, 2005
    Report Date
    June 20, 2005
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LQC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WITH A HISTORY OF MULTIPLE KIDNEY STONES UNDERWENT ESWL TREATMENT ON 3 RENAL STONES; ONE VERY LARGE (20 X 7MM). PROCEDURE COMPLETED WITH NO PROBLEMS. POST-OP HE EXPERIENCED HEMATURIA. THEY WERE READMITTED TO HOSP WITH SYMPTOMATIC PERINEPHRIC HEMATOMA AND REQUIRED FOUR UNITS OF PACKED CELLS. IN 2005, THEY WERE STILL PASSING FRAGMENTS, BUT WAS EXPERIENCING NO FLANK PAIN AT THAT TIME. DOCTOR IS CONTINUING TO MONITOR THEIR CONDITION. HEMATOMAS ARE IDENTIFIED AS A POSSIBLE ADVERSE EVENT & ARE DESCRIBED IN THE LABELING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other