BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH'S 100 ML CASSETTE

    MDR report key: 2190715 · Received July 29, 2011

    Report

    Report Number
    MW5021571
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 29, 2011
    Manufacturer
    SMITH'S MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT STATES THAT THE CASSETTE IS CAUSING THE PUMP TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH'S 100 ML CASSETTE CADD CASSETTE FPA SMITH'S MEDICAL 11X179

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability