BEUDAMED
    FDA Adverse Event Summary report: N

    PIKO 1

    MDR report key: 552809 · Received August 17, 2004

    Report

    Report Number
    MW1032981
    Date Received
    August 17, 2004
    Report Date
    August 11, 2004
    Manufacturer
    PDS-FERRARIS CARDIO RESPIRATORY
    Product Code
    BZH
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOTH PEAK FLOW AND FEV1 READING REGISTER TOO LOW. THIS INFO NEEDED TO PROPERLY MANAGE ASTHMA. CAUSE = FLAP STICKS WHEN YOU BLOW INTO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIKO 1 ELECTRONIC PEAK FLOW BZH PDS-FERRARIS CARDIO RESPIRATORY * *
    2 PIKO 1 FEVI METER BZH PDS-FERRARIS CARDIO RESPIRATORY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * 2004