BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 1152164 · Received August 15, 2008

    Report

    Report Number
    1152164
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 3, 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

    MYNX APPLIED TO RIGHT GROIN, BUT DEVICE FAILED. PT DEVELOPED HEMATOMA, AND WAS HYPOTENSIVE IN CATH LAB. DOPAMINE WAS STARTED AND ANOTHER TYPE OF WOUND CLOSURE DEVICE WAS APPLIED. PT WAS TRANSFERRED TO CCU FOR OBSERVATION. PT BECAME HEMODYNAMICALLY STABLE, AND HEMATOMA RESOLVED. PT WAS DISCHARGED HOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR