BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAD

    MDR report key: 198088 · Received November 19, 1998

    Report

    Report Number
    MW1015011
    Event Type
    Malfunction
    Date Received
    November 19, 1998
    Date of Event
    November 6, 1998
    Report Date
    November 19, 1998
    Manufacturer
    H & P INDUSTRIES, INC.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINTS BY STAFF MEMBER THAT GLYCERINE SWABS LOOKED "MOLDY". VISUAL EXAM OF VARIOUS PACKETS SHOWED A RANGE OF COLOR FROM WHITE TO GREY. PACKAGE SEEMED TO BE SEALED BUT DAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAD LEMON GLYCERINE SWABS KXF H & P INDUSTRIES, INC. * 8H 241

    Patients

    Seq Age Sex Outcome Treatment
    1 *