BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPACT DELTA

    MDR report key: 679432 · Received February 14, 2006

    Report

    Report Number
    679432
    Event Type
    Other
    Date Received
    February 14, 2006
    Date of Event
    February 9, 2006
    Report Date
    February 14, 2006
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    LNS
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LITHOTRIPSY WAS BEING PERFORMED ON A PATIENT. 2500 SHOCKS WERE ADMINISTERED OVER 34 MINUTES. THE MINIMUM VOLTAGE WAS 1 AND THE MAXIMUM VOLTAGE WAS 4. AT THE END OF THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A DIME SIZE BURN/ABRASION ON LEFT LOWER BACK. THE AREA MANAGER REPORTED THIS IS A COMMON INJURY, OCCURRING IN APPROXIMATELY 20% OF USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT DELTA LITHOTRIPSY MACHINE LNS DORNIER MEDTECH AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR