BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3201685 · Received June 28, 2013

    Report

    Report Number
    3006556115-2013-00288
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY DEVELOPED A SKIN FLAP INFECTION. THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 AND PLACED ON IV ANTIBIOTICS (PIPERACILLIN, MEROPENEM, AND CEFTAZIDIME) FOR ONE WEEK. THE PT'S DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297226 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R