BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3960937 · Received June 27, 2014

    Report

    Report Number
    3006556115-2014-00314
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE SKIN FLAP. THE INTERNAL DEVICE WAS EXTRUDING THROUGH THE SKIN. THE PATIENT HAD A WOUND OBSERVATION AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS (CLINDAMYCIN) ON (B)(6), 2014. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT'S INFECTION HAS REPORTEDLY RESOLVED. THE PATIENT WILL BE REIMPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375750 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Hospitalization| R