BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3772371 · Received March 6, 2014

    Report

    Report Number
    3772371
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 13, 2014
    Report Date
    March 6, 2014
    Manufacturer
    UNK
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE OPENING A "TORNETTA EXTREMITY MODULE" IN PREPARATION FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ON BOTH BONES OF LEFT FOREARM, IT WAS NOTICED ONE OF THE WRAPPED LAPAROTOMY PADS HAD AN AREA OF DISCOLORATION (BROWN). THIS LAP PAD WAS REMOVED FROM THE FIELD, LABELED, AND BAGGED. THE SET-UP WAS COMPLETED AND THE PROCEDURE WAS PERFORMED WITHOUT COMPLICATION. NO HARM CAME TO THE PATIENT. THE BAGGED ITEM WAS DELIVERED TO THE O.R. NURSE MANAGER'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137957 UNK LAPAROTOMY PAD FWZ UNK * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *