BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE #2

    MDR report key: 478400 · Received August 14, 2003

    Report

    Report Number
    478400
    Event Type
    Injury
    Date Received
    August 14, 2003
    Date of Event
    August 4, 2003
    Report Date
    August 13, 2003
    Manufacturer
    UNK
    Product Code
    HRQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING C-SECTION. DURING CAUTERIZATION OF SUPERFICIAL BLOOD VESSEL, USING A HEMOSTAT AND BOVIE, THE HEMOSTAT TOUCHED THE SKIN CAUSING A BURN VIA CONDUCTION. THE AREA OF THE SKIN BURN WAS EXCISED AND THE AREA SUTURE. (INVOLVED EQUIPMENT DISCARDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #2 HEMOSTAT HRQ UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention BOVIE