BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3769859 · Received April 3, 2014

    Report

    Report Number
    3769859
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    February 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BOSS INSTRUMENTS, LTD.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE SCREW IN A 3MM KERRISON CAME OUT WHILE ON STERILE FIELD. THE PHYSICIAN WAS AWARE. THE INSTRUMENT WAS REMOVED FROM SERVICE ALONG WITH LOOSE SCREW AND GIVEN TO INSTRUMENT WORKROOM. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203279 * KERRISON RONGEUR HAE BOSS INSTRUMENTS, LTD. 700337 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR