BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROVOX BRUSH

    MDR report key: 924193 · Received October 2, 2007

    Report

    Report Number
    8032044-2007-00015
    Event Type
    Other
    Date Received
    October 2, 2007
    Date of Event
    September 30, 2005
    Report Date
    October 30, 2007
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    EXEMPTED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION HAVE NOT GIVEN ANY CONCLUSIVE EVIDENCE WHY THIS HAS HAPPENED. THE PATIENT HAVE MODIFIED THE BRUSHES BY SHORTENING THEM WITH A PAIR OF PLIERS. THIS MIGHT HAVE CAUSED THE WHITE END TO FALL OFF. PATIENT WAS INSTRUCTED NOT TO MODIFY THE BRUSHES AND THE PROBLEM SEEMS TO HAVE ENDED. CASE HAS BEEN CLOSED. THIS EVENT WAS NOT INITIALLY REPORTED AS AN MDR. DUE TO INCIDENT REPORT 06/29/2007, (MFR # 8032044-2007-00009) REVIEW ACCORDING TO OUR POSTMARKET SURVEILLANCE PROCEDURE OF FORMER SIMILAR EVENTS WAS DONE AND WE DECIDED TO REPORT THIS ISSUE.

    Description of Event or Problem · 1

    THE PATIENT USES APPROX. 1 BRUSH PER MONTH. AT SEVERAL OCCASIONS SHE HAS NOTICED THAT THE WHITE TIP HAS DISAPPEARED. PATIENT HAS NOT EXPERIENCED ANY DISCOMFORT AND DOES NOT KNOW WHEN THE TIP HAS DISAPPEARED. NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX BRUSH CLEANING BRUSH FOR VOICE PROSTHESIS EWL ATOS MEDICAL AB PROVOX BRUSH 0412008

    Patients

    Seq Age Sex Outcome Treatment
    1 YR