BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFLEX

    MDR report key: 18144 · Received November 2, 1994

    Report

    Report Number
    18144
    Event Type
    Malfunction
    Date Received
    November 2, 1994
    Date of Event
    October 25, 1994
    Report Date
    November 2, 1994
    Manufacturer
    PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO PAIR OF SURGEON'S GLOVES WERE PACKAGED WITH TORN GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFLEX SURGEON'S GLOVES KGO PHARMASEAL DIV., BAXTER HEALTHCARE CORP. PGS4H032

    Patients

    Seq Age Sex Outcome Treatment
    1 *