BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1171173 · Received September 22, 2008

    Report

    Report Number
    3006556115-2008-00489
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY DEVELOPED AN INFECTION AT HER IMPLANT SITE. THE PT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (TYPE UNKNOWN). THE PT REPORTEDLY HAD AN ALLERGIC REACTION TO ONE OF THE PRESCRIBED MEDICATION (TYPE UNKNOWN). THE PATIENT DEVELOPED A SORE AT THE IMPLANT SITE. ADVANCED BIONICS IS CONTINUING TO BE INVESTIGATE THIS AND ONCE MORE INFO IS AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. CI-14001-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention