BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1250674 · Received December 2, 2008

    Report

    Report Number
    3006556115-2008-00645
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    August 5, 2005
    Report Date
    November 11, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. IN 2005, THE PATIENT WAS SEEN BY THE DOCTOR AND THE PATIENT'S MOTHER REPORTED THAT THE PATIENT HAS NO COMPLAINTS, AND IS DOING WELL WITH NO FEVERS. THE PATIENT'S DEVICE REMAINED IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT HAD PE TUBES REMOVED DURING THE IMPLANT SURGERY. DUE TO THE PE TUBES REMOVAL, THREE DAYS AFTER THE INITIAL SURGERY, THE PATIENT REPORTEDLY HAD BLOODY OTORRHEA. THE PATIENT WAS SEEN BY THE DOCTOR IN 2005, AND THE PATIENT WAS DIAGNOSED WITH RIGHT POSTOPERATIVE HEMATOMA. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED TO INCISE AND DRAIN THE HEMATOMA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Hospitalization| R