BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX

    MDR report key: 1103403 · Received August 7, 2008

    Report

    Report Number
    MW5007927
    Event Type
    Injury
    Date Received
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LARGE HEMATOMA DEVELOPED AFTER DEPLOYMENT OF MYNX CLOSURE VASCULAR DEVICE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: NEW PRODUCT INTRODUCTION / PHYSICIAN PREFERENCE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX MYNX MGB ACCESS CLOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other MANUAL HOLD TO GROIN HEMATOMA SITE