BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 3874056 · Received May 28, 2014

    Report

    Report Number
    3006556115-2014-00253
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY HAD RETENTION ISSUES. THE PATIENT UNDERWENT REVISION SURGERY TO THIN THE SKIN FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314207 NI COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention