BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MGB

    MDR report key: 5442884 · Received February 17, 2016

    Report

    Report Number
    3004939290-2016-00032
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    November 12, 2015
    Report Date
    January 21, 2016
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    PO40044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION WAS NOT PERFORMED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A LOT HISTORY REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER THE INSTRUCTIONS FOR USE (IFU). THE MYNX DEVICE IS TERMINALLY STERILIZED AND SUBJECTED TO LAL (LIMULUS AMEBOCYTE LYSATE) TESTING TO ENSURE THE PRODUCT MEETS STERILIZATION AND BACTERIAL ENDOTOXIN REQUIREMENTS, PRIOR TO EACH LOT BEING RELEASED FOR COMMERCIAL USE. ADDITIONALLY THE IFU STATES THAT, "THE FOLLOWING ADVERSE REACTIONS OR CONDITIONS MAY ALSO BE ASSOCIATED WITH MYNX OR WITH THE DIAGNOSTIC OR INTERVENTIONAL PROCEDURE: ALLERGIC REACTION, FOREIGN BODY REACTION, INFECTION, INFLAMMATION, OR VESSEL LACERATION". SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE WAS UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL AT AN UNKNOWN TIME FOLLOWING A MYNXGRIP VASCULAR CLOSURE DEVICE PROCEDURE WITH A LOCALIZED REACTION MANIFESTED BY REDNESS AT THE ACCESS SITE. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AT THAT TIME AND THE WOUND WAS SURGICALLY OPENED AND INFLAMMATORY TISSUE WAS OBSERVED. CULTURES WERE PERFORMED AND THE RESULTS WERE NEGATIVE FOR INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97511 MGB MGB CARDINAL HEALTH NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention