BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2901141 · Received January 4, 2013

    Report

    Report Number
    3006556115-2012-00592
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 6, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT HAD A SMALL WOUND AT THE IMPLANT SITE THAT BECAME DEHISCENT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE MORE INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4637 NI COHLEAR IMPLANT MCM ADVANCED BIONICS LLC NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention