BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOOD WORKS PERFORMANCE PRO NITRILE EXAM GLOVES

    MDR report key: 23532990 · Received November 12, 2025

    Report

    Report Number
    MW5178747
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 6, 2025
    Manufacturer
    AMERICAN NITRILE OPERATIONS LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GLOVES APPLIED PER TECH FOR PROCEDURE-- "CUFF" PORTION OF GLOVES RIPPED AND TATTERED. GOOD WORKS- PERFORMANCE PRO (BOSMA) SIZE- MEDIUM LOT # 72-50602 MANUFACTURE : AN (B)(4) 25-01-26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140210 GOOD WORKS PERFORMANCE PRO NITRILE EXAM GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA AMERICAN NITRILE OPERATIONS LLC 72-50602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown