BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVOX2 VOICE PROSTHESIS

    MDR report key: 864711 · Received May 29, 2007

    Report

    Report Number
    8032044-2007-00005
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Report Date
    May 28, 2007
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    K971244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLUE RING WAS MISSING WHEN THE PRODUCT WAS RETURNED. GLUE RESIDUE INSIDE THE PROSTHESIS SHOWS THAT THE MISSING RING HAS BEEN GLUED TO THE PROSTHESIS ACCORDING TO SPEC. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING INSERTION THE DOCTOR DISCOVERED THAT THE BLUE RING (VALVE SEAT) INSIDE THE PROSTHESIS WAS MISSING. THE DOCTOR TRIED TO INSERT THE PROSTHESIS ANYWAY, BUT IT DID NOT WORK. THE DOCTOR INITIALLY CLAIMED THAT THE BLUE RING WAS MISSING WHEN THE PRODUCT WAS OPENED, BUT WAS LATER UNCERTAIN IF IT HAD BEEN THERE OR NOT. PT HAVE BEEN X-RAYED TO CONFIRM THAT THE BLUE RING DIDN'T FALL INTO THE TRACHEA OF THE PT. NO EFFECT ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX2 VOICE PROSTHESIS VOICE PROSTHESIS EWL ATOS MEDICAL AB PROVOX2 6MM 0611080

    Patients

    Seq Age Sex Outcome Treatment
    1 YR