BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE MOSKAL TOTAL HIP PACK

    MDR report key: 3853113 · Received April 28, 2014

    Report

    Report Number
    3853113
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    DURING A TOTAL HIP PROCEDURE, THE ELECTROSURGICAL HANDPIECE THAT IS INCLUDED IN THE MEDLINE MOSKAL TOTAL HIP PACK MALFUNCTIONED. THE DEVICE WAS ACTIVELY FIRING WITHOUT SURGEON MANUALLY STARTING IT. NO INJURY OCCURRED, BUT POTENTIALLY COULD HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254797 MEDLINE MOSKAL TOTAL HIP PACK GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. * 14MB4597

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR