BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVOX 2 VOICE PROSTHESIS

    MDR report key: 2973812 · Received August 30, 2007

    Report

    Report Number
    8032044-2007-00013
    Event Type
    Malfunction
    Date Received
    August 30, 2007
    Date of Event
    July 16, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED AND REPORTED IN CONNECTION WITH FOLLOW-UP REPORT REGARDING MFR. REPORT # 8032044-2007-00004 DATED (B)(4) 2007.

    Description of Event or Problem · 1

    DURING PREPARATION, THE BLUE VALVE RING WAS DISLODGED IN THE LOADING TUBE. PATIENT WAS NEVER AFFECTED. A NEW PROVOX2 WAS INSERTED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX 2 VOICE PROSTHESIS VOICE PROSTHESIS EWL ATOS MEDICAL AB PROVOX2 6 MM 0611027

    Patients

    Seq Age Sex Outcome Treatment
    1