BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 5392555 · Received January 27, 2016

    Report

    Report Number
    5392555
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    January 11, 2016
    Report Date
    January 21, 2016
    Manufacturer
    N/A
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FIFTEEN BLADE WAS BEING USED DURING THE SURGICAL PROCEDURE. IT BROKE IN HALF DURING USE. THE SURGICAL TECH REPORTED IT TO THE NURSE AND BOTH PIECES WERE COUNTED AND PUT ONTO THE COUNTING BOARD. BOTH PIECES WERE ACCOUNTED FOR AT THE TIME AND DURING THE FINAL COUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50697 BARD-PARKER BLADE, SCALPEL GES N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR