BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVERSE LAPAROTOMY CUSTOM PBDS MODULE PACK

    MDR report key: 3242774 · Received July 17, 2013

    Report

    Report Number
    MW5030977
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 17, 2013
    Manufacturer
    COVIDIEN/VALLEY LAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED 3 MINOR (<.3MM) SKIN BURNS ON ABDOMEN WHEN CAUTERY PENCIL WAS ACTIVATED. A BURN HOLE WAS IDENTIFIED IN THE CORD INSULATION 26" FROM THE PENCIL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332111 TRANSVERSE LAPAROTOMY CUSTOM PBDS MODULE PACK CAUTERY PENCIL/CORD GEI COVIDIEN/VALLEY LAB 962571

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention