BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1140106 · Received August 28, 2008

    Report

    Report Number
    3006556115-2008-00447
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING REPEATED EAR INFECTIONS AND TENDERNESS AT HER INCISION SITE. VISUAL INSPECTION OF THE SITE REVEALED NO REDNESS OR IRRITATION. THE PT REPORTS THAT HER INFECTION WAS MANAGED BY A LOCAL PHYSICIAN. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO, ONCE MORE INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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