BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1062105 · Received June 18, 2008

    Report

    Report Number
    3006556115-2008-00321
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING IRRITATION AT THE IMPLANT SITE. THE PT HAS NOT USED EXTERNAL EQUIPMENT DUE TO THE SKIN BEING SENSITIVE. THE PT IS TAKING MEDICAMENTS (TYPE UNK) AGAINST THE INFLAMMATION PROCESS. SURGERY TO CLOSE THE PT'S WOUND WILL BE SCHEDULED.

    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 Required Intervention