BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADPIECE - S-SERIES

    MDR report key: 1840890 · Received September 13, 2010

    Report

    Report Number
    3006556115-2010-00441
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 23, 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 COMPANY WAS INFORMED THAT THE PATIENT REPORTEDLY DEVELOPED A SKIN FLAP INFECTION AT THE HEADPIECE SITE. THE PATIENT WAS TREATED FOR TWO WEEKS WITH ORAL ANTIBIOTICS (TYPE UNK). THE PATIENT'S INFECTION REPORTEDLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEADPIECE - S-SERIES HEADPIECE MCM ADVANCED BIONICS LLC MMT-5300-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention