BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3812820 · Received May 6, 2014

    Report

    Report Number
    3006556115-2014-00205
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    February 26, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT DEVELOPED AN OPEN WOUND AT THE IMPLANT SITE. ON (B)(6) 2014 SURGERY WAS PERFORMED TO REPOSITION THE PATIENT'S IMPLANTED DEVICE, THE SKIN FLAP WAS REVISED AND RESUTURED. DERMABOND WAS USED ON THE INCISION SITE ON (B)(6) 2014. SWELLING WAS OBSERVED AROUND THE IMPLANT SITE ON (B)(6) 2014. THE PATIENT UNDERWENT EXPLORATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2014. BENZAMYCIN POWDER WAS USED ON THE SITE AND CLOSED. THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2014. THE PATIENT IS CURRENTLY BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271666 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Required Intervention