BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACMI

    MDR report key: 746873 · Received October 31, 2005

    Report

    Report Number
    MW1037062
    Event Type
    Other
    Date Received
    October 31, 2005
    Date of Event
    September 9, 2005
    Report Date
    October 31, 2005
    Manufacturer
    ACMI
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGERY TO REMOVE KIDNEY STONES. PLASTIC SHEATH BROKE OFF FROM HELICAL BASKET. SURGEON HAD TO RETRIEVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACMI SURLOCK HELICAL STONE BASKET FFL ACMI REP 5700006 1485605E

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other NO KNOWN