BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROVOX BRUSH

    MDR report key: 924691 · Received October 10, 2007

    Report

    Report Number
    8032044-2007-00016
    Event Type
    Other
    Date Received
    October 10, 2007
    Date of Event
    June 30, 2006
    Report Date
    October 30, 2007
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EPE
    PMA / PMN Number
    B077066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE HAVE BEEN EXAMINED AND CORRECT HANDLING IS CLEARLY DESCRIBED. IN ORDER TO DROP THE BRUSH INTO THE TRACHEA, IT MUST BE USED COMPLETELY IN VIOLATION WITH THE INSTRUCTIONS FOR USE. THE HOSPITAL HAS DONE THE SAME ASSESSMENT OF THE EVENT AND THEY HAVE NOT REPORTED IT TO THE AUTHORITIES. THE PT HAS BEEN INFORMED ON CORRECT USE OF THE BRUSH. CASE HAS BEEN CLOSED. THIS EVENT WAS NOT INITIALLY REPORTED AS AN MDR. DUE TO INCIDENT REPORT 6/29/2007, (MFR #8032044-2007-00009) REVIEW OF FORMER SIMILAR EVENTS WAS DONE AND WE DECIDED TO REPORT THIS ISSUE.

    Description of Event or Problem · 1

    DURING A PT MEETING IN ANOTHER COUNTRY, A PT INFORMED OUR REP THAT HE SOME TIME AGO HAD SOME LUNG PROBLEMS AND WENT TO SEE A DOCTOR. X-RAY REVEALED A PROVOX BRUSH IN THE LUNG WHICH CONSEQUENTLY WAS REMOVED. THE PT DID NOT FEEL ANY DISCOMFORT AFTERWARDS. OUR REP FORWARDED THE INFO TO US AS A COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX BRUSH CLEANING BRUSH FOR VOICE PROSTHESIS EPE ATOS MEDICAL AB PROVOX BRUSH 0502005 (UNCERTAIN)

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention