BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPPORTUNITY FLEX

    MDR report key: 25170005 · Received May 14, 2026

    Report

    Report Number
    25170005
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 6, 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 A PERIODICAL FOLLOW UP REPORT RELATED TO PREVIOUSLY SUBMITTED FDA MEDSUN REPORT REGARDING AMERICAN NITRILE NITRILE EXAMINATION GLOVE FAILURES. BETWEEN (B)(6) 2026, THERE WERE 125 TOTAL REPORTS OF GLOVE FAILURES EXPERIENCED ACROSS 29 FACILITIES AND 14 [REDACTED] NETWORKS. THE REPORTS OF GLOVE FAILURES INCLUDED REPORTS FOR OPPORTUNITY PRO, OPPORTUNITY FLEX, AND GOODWORKS PERFORMANCE PRO BRANDS. AN ESTIMATED AT LEAST 960 NITRILE EXAMINATION GLOVES FAILED IN THIS TIME PERIOD. TYPES OF ISSUES/FAILURES INCLUDED: TEARS/RIPS, GLOVES STUCK TOGETHER, MISSING PARTS OF GLOVES, FOREIGN SUBSTANCES (DIRT/MOLD), INCONSISTENT GLOVE THICKNESS, SIZE TOO SMALL, SIZE TOO LARGE, AND OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139755 OPPORTUNITY FLEX POLYMER PATIENT EXAMINATION GLOVE LZA AMERICAN NITRILE OPERATIONS, LLC 72-50902, MANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other