BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROVOX BRUSH

    MDR report key: 924194 · Received October 1, 2007

    Report

    Report Number
    8032044-2007-00014
    Event Type
    Other
    Date Received
    October 1, 2007
    Date of Event
    September 5, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRUSH WAS HEAVILY OVERUSED AND THE BRISTLES WERE ALL LAYING DOWN POINTING FORWARD, WHICH COMPLETELY MADE THE BRUSH UNSUITABLE FOR USE. LOT NO IS UNKNOWN, BUT DESIGN SHOWS THAT THE BRUSH WAS APPROXIMATELY 2 YEARS OLD WHEN INCIDENT OCCURRED. IN THE MANUAL UNDER PATIENT COUNSELING IT IS STATED: "THE BRUSH CAN BE USED AS LONG AS IT APPEARS CLEAN AND SHOWS NO DEFECTS (USUALLY SEVERAL WEEKS)." CONCLUSION: THE BRISTLES OF THE ACTUAL BRUSH WERE COMPLETELY DESTROYED. THE PATIENT HAD USED THE BRUSH WELL BEYOND ITS ESTIMATED LIFETIME MAKING THE BRUSH BREAK. PATIENT WAS INFORMED ABOUT THE CORRECT USE OF THE BRUSH AND HIGHLIGHTED ON THE IMPORTANCE OF CHECKING AND CHANGING THE BRUSH ACCORDING TO IFU. CASE HAS BEEN CLOSED. THIS EVENT WAS NOT INITIALLY REPORTED AS AN MDR. DUE TO INCIDENT REPORT IN 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

    THE BRUSH BROKE IN HALF. IT BROKE OUTSIDE OF THE STOMA. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR