BEUDAMED
    FDA Adverse Event Summary report: N

    FLOW MARK

    MDR report key: 10523 · Received November 16, 1993

    Report

    Report Number
    MW4000048
    Date Received
    November 16, 1993
    Manufacturer
    SPIROMETRICS, INC.
    Product Code
    BTY
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT WAS AT THE HOSP FOR PULMONARY TESTS. HE WAS TAKING THE TEST WHEN THE FILTER OF THE DEVICE BECAME DISLODGED AND THE PT INGESTED IT, WHILE DOING THE BREATHING EXERCISES OF INHALING AND EXHALING. RPTR SAID THAT HIS CO LISTS AS THE INSTRUCTIONS FOR USE, TO CHANGE THE FILTER EVERY TIME A PT TAKES A TEST. RPTR SAID THAT THE HOSP WAS NOT DOING SO, AND THE FILTER BECAME OVERUSED AND DISLODGED, CAUSING THE PT TO INGEST IT. RPTR SAID THAT THE HOSP X-RAYED THE PT AND FOUND THAT THE FILTER WAS LODGED IN HIS STOMACH, AND IT WILL BE EXPELLED THRU NORMAL EVACUATION. THE MFRS ARE SENDING A TEAM OF EXPERTS TO THE HOSP TO INVESTIGATE THE INCIDENT. THEY ALSO HAVE TOLD HOSP PERSONNEL NOT TO USE THE DEVICE UNTIL IT IS CHECKED FOR ALL POSSIBLE MALFUNCTIONS. RPTR WAS QUESTIONED ON THE POSSIBILITY OF HEALTH HAZARD TO PTS ON THE USE OF THE SAME FILTER, AND GERMS PROPAGATION FROM ONE PT TO THE OTHER. HE SAID THAT ONLY PTS WITH T.B. AND OTHER DISEASES COULD HAVE CAUSE TO SPREAD INFECTIONS, IF THE FILTER WAS NOT CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW MARK BTY SPIROMETRICS, INC. 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 *