BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLDYNE 2500 EXCERCISER

    MDR report key: 40097 · Received September 16, 1996

    Report

    Report Number
    1915484-1996-00001
    Event Type
    Malfunction
    Date Received
    September 16, 1996
    Date of Event
    August 16, 1996
    Report Date
    August 16, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A UNIT WAS BEING USED BY A PT. A PIECE OF PLASTIC WAS SUCKED INTO THE PT'S THROAT. THE PT COUGHED UP THE PLASTIC PIECE. NO FOLLOW-UP TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLDYNE 2500 EXCERCISER BREATHING EXCERCISER BWF SHERWOOD DAVIS AND GECK NA 301832

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR