BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPPORTUNITY FLEX

    MDR report key: 24769263 · Received April 2, 2026

    Report

    Report Number
    24769263
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 30, 2026
    Manufacturer
    AMERICAN NITRILE OPERATIONS, LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS FOR REPORTS RECEIVED FROM DEC 12, 2025 TO FEB 28, 2026. AN ESTIMATED AT LEAST 5,435 NUMBER OF NITRILE EXAMINATION GLOVES FAILED IN THIS TIME PERIOD. ISSUES PERTAINING TO: TEARS/RIPS, MISSING PARTS OF GLOVES, FOREIGN SUBSTANCES (DIRT/MOLD), GLOVES STUCK TOGETHER, INCONSISTENT GLOVE THICKNESS, SIZE TOO SMALL, REACTION TO MATERIAL BY STAFF, SIZE TOO LARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828367 OPPORTUNITY FLEX POLYMER PATIENT EXAMINATION GLOVE LZA AMERICAN NITRILE OPERATIONS, LLC 72-50902,

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other