BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMOSTOP PLUS

    MDR report key: 679858 · Received January 9, 2006

    Report

    Report Number
    679858
    Event Type
    Malfunction
    Date Received
    January 9, 2006
    Date of Event
    January 3, 2006
    Report Date
    January 9, 2006
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF WAS PREPARING TO USE THE DEVICE AND OPENED THE NEW PACKAGE. THE BELT THAT SECURES THE DEVICE IS NORMALLY LOCATED INSIDE THE PACKAGING, INSIDE THE DIRECTIONS. WHEN STAFF OPENED THE BOX, THERE WAS NO BELT. ALL OTHER COMPONENTS WERE PRESENT, BUT WITHOUT THE BELT, THE DEVICE CANNOT BE USED. STAFF OPENED ANOTHER BOX, WHICH DID HAVE ALL PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMOSTOP PLUS COMPRESSION SYSTEM MGB RADI MEDICAL SYSTEMS AB * 052115
    2 FEMOSTOP PLUS COMPRESSION SYSTEM MGB RADI MEDICAL SYSTEMS AB * 052115

    Patients

    Seq Age Sex Outcome Treatment
    1 *