BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM BTE PROCESSOR

    MDR report key: 1213964 · Received October 28, 2008

    Report

    Report Number
    3006556115-2008-00576
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED SWELLING AT THE IMPLANT SITE DUE TO EXTERNAL EQUIPMENT BECOMING HOT. THE PT WAS PRESCRIBED RINDERON -VG CREAM. THE SWELLING AT THE IMPLANT SITE SUBSIDED AND NO IRRITATION WAS OBSERVED. THE COMPANY IS IN THE PROCESS OF GATHERING ADD'L INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFO IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM BTE PROCESSOR BTE PROCESSOR MCM ADVANCED BIONICS LLC CI-5210-310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention