BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFLEX LATEX SURGEON'S GLOVE

    MDR report key: 14585 · Received July 8, 1994

    Report

    Report Number
    MW1002769
    Event Type
    Malfunction
    Date Received
    July 8, 1994
    Date of Event
    January 1, 1994
    Report Date
    May 25, 1994
    Manufacturer
    BAXTER HEALTHCARE SYSTEM
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFECTION RATE INCREASE PROMPTED REVIEW OF PRODUCTS IN SPECIFIC DEPT. SURGICAL GLOVES WERE FOUND TO RIP EASILY AND HAVE PINE HOLES. RANDOM SAMPLING OF SOME GLOVES THROUGHOUT FACILITY PRODUCED SIMILAR FINDINGS. MGR WAS NOTIFIED AND REPLACED ALL CURRENT STOCK WITH GLOVES FROM A DIFFERENT CATALOGUE NUMBER WHICH WERE SAME ITEM, THOUGH MFG DIFFERENTLY USING DOUBLE-DIP METHOD. SOME PROBLEMS WERE IDENTIFIED AND ALL REPLACEMENT GLOVES REMOVED FROM SVC. (ALSO SEE 1002768.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFLEX LATEX SURGEON'S GLOVE STERILE LATEX GLOVE KGO BAXTER HEALTHCARE SYSTEM UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA