BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVOX BRUSH

    MDR report key: 1163329 · Received September 10, 2008

    Report

    Report Number
    8032044-2008-00003
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    April 14, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    EXEMPTED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CONTINUING OUR INVESTIGATION ON THIS EVENT. CURRENTLY NO ACTIONS ARE CONSIDERED TO BE NECESSARY. (B) (4).

    Description of Event or Problem · 1

    THE PATIENT CLAIMS TO HAVE USED A PROVOX BRUSH AND THAT IT BROKE-OFF WHILE SHE WAS CLEANING HER PROSTHESIS. SHE REQUIRED MEDICAL INTERVENTION TO HAVE THE BRUSH REMOVED FROM THE TRACHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX BRUSH VOICE PROSTHESIS CLEANING BRUSH EWL ATOS MEDICAL AB PROVOX BRUSH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention