BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 1152138 · Received August 15, 2008

    Report

    Report Number
    1152138
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ACCESS CLOSURE INC
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    RIGHT GROIN OOZING BLOOD STATUS POST MYNX PRESSURE AND ADDED BEDREST. RESOLVED WITHOUT HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSER DEVICE MGB ACCESS CLOSURE INC * F0815704

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR