BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE ANGIOGRAPHY PACK

    MDR report key: 3969977 · Received July 25, 2014

    Report

    Report Number
    3969977
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OFH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE WIRE WAS BROKEN WHEN IT WAS PULLED OUT OF THE HOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436651 MEDLINE ANGIOGRAPHY PACK ANGIOGRAPHY/ANGIOPLASTY KIT OFH MEDLINE INDUSTRIES, INC. * 14QB7612

    Patients

    Seq Age Sex Outcome Treatment
    1 *