BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT DELTA LITHOTRIPTER UNIT CD-424

    MDR report key: 1055365 · Received June 2, 2008

    Report

    Report Number
    1037955-2008-00004
    Event Type
    Injury
    Date Received
    June 2, 2008
    Date of Event
    March 19, 2008
    Report Date
    May 29, 2008
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CHECKED BY DORNIER MEDTECH AMERICA, INC. SERVICE ENGINEERS, AND FOUND TO BE OPERATING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PERI RENAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT DELTA LITHOTRIPTER UNIT CD-424 LITHOTRIPTER LNS DORNIER MEDTECH AMERICA, INC. COMPACT DELTA CD-424

    Patients

    Seq Age Sex Outcome Treatment
    1 Other