BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUME PEN

    MDR report key: 3833687 · Received May 21, 2014

    Report

    Report Number
    MW5036220
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    BUFFALO FILTER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ACTIVATED THE PLUME PEN FOR USE DURING A SURGICAL PROCEDURE. THE BUTTON SWITCH ON THE PEN DID NOT DEACTIVATE RESULTING IN A BURN TO THE PT. THE PHYSICIAN WAS ABLE TO REPLICATE THE EVENT WITH A DEMONSTRATION ON HOW THE PEN BUTTON GOT "STUCK" IN ACTIVATED MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301257 PLUME PEN PLUME PEN GEI BUFFALO FILTER PLP1020 130801032

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention