BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MGB

    MDR report key: 5134909 · Received October 8, 2015

    Report

    Report Number
    3004939290-2015-00451
    Event Type
    Injury
    Date Received
    October 8, 2015
    Report Date
    September 15, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED BY THE PATIENT: I GOT MY MYNX PROCEDURE DONE AFTER A HEART BLOCKAGE PROCEDURE. WHEN I TOOK THE BANDAGE OFF, I NOTICED A BIG KNOT. IS THIS NORMAL? ON 09/25/2015, THE COMPANY REPRESENTATIVE EMAILED COMPLAINT HANDLING WITH THE FOLLOWING INFORMATION: I SPOKE TO THE DOCTOR AND WAS TOLD THE PATIENT NEVER CONTACTED HIM. I EXPLAINED WHAT HAD HAPPENED AND HE HAD NO CONCERN ABOUT HER GROIN. ON 10/02/2015, CARDINAL HEALTH COMPLAINT HANDLING FOLLOWED UP AGAIN WITH THE COMPANY REPRESENTATIVE TO REQUEST THAT HE FOLLOWS UP WITH THE DOCTOR AGAIN TO INQUIRE IF THE PATIENT CALLED REGARDING THE REPORTED KNOT AT HER GROIN. ON 10/02/2015, THE COMPANY REPRESENTATIVE CALLED COMPLAINT HANDLING BACK AND REPORTED THAT THE DOCTOR STATED VIA A TEXT MESSAGE THAT THE PATIENT DID NOT CONTACT HIM REGARDING THE KNOT AT THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667401 MGB MGB CARDINAL HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other