BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3424196 · Received September 23, 2013

    Report

    Report Number
    3424196
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    September 3, 2013
    Report Date
    September 23, 2013
    Manufacturer
    LIFE INSTRUMENT CORP
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    3MM KERRISON HAD A PIECE OF THE HANDLE BREAK OFF ON THE STERILE FIELD. THE KERRISON AND THE BROKEN PIECE WERE HANDED OFF THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479034 * RONGEURS HTX LIFE INSTRUMENT CORP 837-8003-0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR