BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVOX2 VOICE PROSTHESIS

    MDR report key: 889050 · Received July 24, 2007

    Report

    Report Number
    8032044-2007-00012
    Event Type
    Malfunction
    Date Received
    July 24, 2007
    Date of Event
    April 1, 2007
    Report Date
    July 24, 2007
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    K971244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED AND REPORTED IN CONNECTION WITH FOLLOW-UP REPORT REGARDING MFR REPORT #8032044-2007-00004.

    Description of Event or Problem · 1

    DR PODAR HAS INSERTED THE PROVOX2 6 MM TO PT. AFTER INSERTION, THE PROSTHESIS STARTED LEAKING IMMEDIATELY AND AFTER ABOUT AN HOUR BLUE RING CAME OUT. SO IMMEDIATELY THE PROSTHESIS WITHOUT BLUE RING IS TAKEN OUT. A NEW PROVOX2 IS WAS INSERTED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX2 VOICE PROSTHESIS VOICE PROSTHESIS EWL ATOS MEDICAL AB PROVOX2 6MM 0701065

    Patients

    Seq Age Sex Outcome Treatment
    1 YR