BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLDYNE 2500 EXERCISER

    MDR report key: 38350 · Received August 29, 1996

    Report

    Report Number
    38350
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Date of Event
    August 16, 1996
    Report Date
    August 28, 1996
    Manufacturer
    SHERWOOD MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT COUGHED UP A PIECE OF HARD PLASTIC. SHE STATES THAT WHILE DOING INCENTIVE SPIROMETRY, A PIECE OF PLASTIC WENT INTO HER CHEST AND SHE COUGHED IT OUT. UNSURE IF ALL PIECES OF PLASTIC WERE EXPELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLDYNE 2500 EXERCISER INCENTIVE SPIROMETRY BWF SHERWOOD MEDICAL VOLDYNE 2500 301832

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other