BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING

    MDR report key: 4251398 · Received October 31, 2014

    Report

    Report Number
    4251398
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 31, 2014
    Manufacturer
    KIMBERLY CLARK CORP.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THERE HAS BEEN A "RUN" OF DEFECTIVE GLOVES: FINGERTIPS HAVE EXTRA PIECES OF GLOVE IN THEM ALTERING PROPER FIT, FINGERTIPS ARE SPLITTING OPEN OR THE CUFF OF THE GLOVE INTO THE PALM AREA RIP OPEN.======================MANUFACTURER RESPONSE FOR EXAM GLOVES, STERLING NITRILE POWDER FREE EXAM GLOVES (PER SITE REPORTER).======================IT IS MY UNDERSTANDING THAT THE BOXES ARE BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698673 STERLING EXAM GLOVES LZA KIMBERLY CLARK CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *