BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1901442 · Received November 4, 2010

    Report

    Report Number
    3006556115-2010-00537
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED A SKIN FLAP INFECTION. THE PT WAS TREATED WITH ANTIBIOTICS (TYPE UNK). THE PT'S INFECTION HAS REPORTEDLY RESOLVED AS OF (B)(6) 2010. THE COMPANY CONTINUES TO GATHER INFO. WHEN 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, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention