BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 2887421 · Received December 20, 2012

    Report

    Report Number
    MW5028258
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    August 30, 2012
    Report Date
    December 20, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED A FULL THICKNESS BURN TO HER RIGHT BUTTOCK DURING A SPINAL SURGERY. INVESTIGATION DETERMINED THAT THE COVIDIEN CAUTERY DEVICE, NOT IN USE (STORED IN POUCH ONLY, ATTACHED TO DRAPE), WAS LEANED ON BY SURGEON DURING SURGERY AND IGNITED THE DRAPE. FLAMES EXTINGUISHED IMMEDIATELY AND NO OTHER INJURIES SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN CAUTERY DEVICE GEI COVIDIEN NOT PRESENT ON

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention