BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAVAC 100

    MDR report key: 935430 · Received October 1, 2007

    Report

    Report Number
    935430
    Event Type
    Malfunction
    Date Received
    October 1, 2007
    Date of Event
    September 14, 2007
    Report Date
    October 1, 2007
    Manufacturer
    DAVOL, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE DAVOL, INC. DRAINS WERE FOUND TO BE DYSFUNCTIONAL WHEN THEY WERE HOOKED UP TO THE SUCTIONING DEVICE. ALL THREE WERE NOTED TO BE BUBBLING WHEN CONNECTED TO THE SUCTIONING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIAVAC 100 DRAIN, BULB GCY DAVOL, INC. * NGRE0585

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR