BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIEPRO PLUS NITRILE GLOVES

    MDR report key: 8897689 · Received August 9, 2019

    Report

    Report Number
    8897689
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 7, 2019
    Manufacturer
    SPS GLOBAL
    Product Code
    LZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GLOVES APPLIED. CLUMP OF MATERIAL FELT IN FINGERTIP. GLOVE REMOVED AND BROWN CLUMP NOTED INSIDE OF GLOVE FINGERTIP. BOX OF GLOVES REMOVED FROM USE. THIS IS A DIFFERENT LOT NUMBER THEN WAS REPORTED ON 450462-2019-006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671793 PREMIEPRO PLUS NITRILE GLOVES EXAM GLOVES LZC SPS GLOBAL MTI02-04

    Patients

    Seq Age Sex Outcome Treatment
    1