BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSOL DRAINAGE BAG, "Y" ADAPTOR

    MDR report key: 654294 · Received September 22, 2005

    Report

    Report Number
    9680866-2005-00003
    Event Type
    Malfunction
    Date Received
    September 22, 2005
    Date of Event
    August 25, 2005
    Report Date
    September 20, 2005
    Manufacturer
    UNOMEDICAL INC.
    Product Code
    BYH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING ITEM 974Y-E ON A PT, THE BAG CAME LOOSE FROM THE WYE ATTACHMENT. PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROSOL DRAINAGE BAG, "Y" ADAPTOR DRAINAGE BAG BYH UNOMEDICAL INC. 974Y-E 03-48

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other