BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURE GLOVE NITRILE DISPOSABLE GLOVES

    MDR report key: 11154012 · Received January 12, 2021

    Report

    Report Number
    11154012
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    December 23, 2020
    Report Date
    January 11, 2021
    Manufacturer
    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LABELED AS POWDER FREE BUT SOME GLOVES HAVE BEEN FOUND WITH POWDER IN THEM.

    Description of Event or Problem · 1

    LABELED AS POWDER FREE BUT SOME GLOVES HAVE BEEN FOUND WITH POWDER IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51656 PURE GLOVE NITRILE DISPOSABLE GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. PNG617 3NS2606204

    Patients

    Seq Age Sex Outcome Treatment
    1