BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 619193 · Received June 22, 2005

    Report

    Report Number
    2020550-2005-00012
    Event Type
    Other
    Date Received
    June 22, 2005
    Date of Event
    May 6, 2005
    Report Date
    June 21, 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 CHRONIC COUMADIN MANAGEMENT UNDERWENT ESWL TREATMENT ON 2 RENAL STONES (9 AND 2MM). PROCEDURE COMPLETED WITH NO PROBLEMS. POST-OP PT HAD A BLEEDING EPISODE NECESSITATING A BLOOD TRANSFUSION. THEY STATE THEY ARE RETURNING TO NORMAL STATE OF HEALTH SINCE HOSPITALIZATION. DOCTOR IS PRESENTLY MONITORING PT'S CONDITION. HEMATOMAS ARE IDENTIFIED AS A POSSIBLY ADVERSE EVENT AND ARE DESCRIBED IN THE LABELING. THERE IS ALSO A WARNING IN THE MANUAL THAT ANTICOAGULANTS SHOULD BE TEMPRORILY DISCONTINUED PRIOR TO EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY TO PREVENT SEVERE HEMORRHAGE.

    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 53 YR Other