BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOOD WORKS PERFORMANCE PRO

    MDR report key: 23407790 · Received October 28, 2025

    Report

    Report Number
    MW5178167
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 24, 2025
    Manufacturer
    AMERICAN NITRILE OPERATIONS LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GLOVE DEFECT. TORN GLOVE WHEN APPLYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213065 GOOD WORKS PERFORMANCE PRO POLYMER PATIENT EXAMINATION GLOVE LZA AMERICAN NITRILE OPERATIONS LLC A001398 1-4-250702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown