BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPPORTUNITY PRO NITRILE EXAM GLOVE

    MDR report key: 23631531 · Received November 24, 2025

    Report

    Report Number
    MW5179346
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 19, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BOSMA INDUSTRIES FOR THE BLIND, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BOX OF SMALL GLOVES WERE OPENED AND IT WAS NOTED THAT THERE WAS OIL ON THE GLOVE. WE HAVE HAD MULTIPLE INSTANCES OVER THE LAST YEAR ABOUT GLOVES SHOWING THIS OIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578051 OPPORTUNITY PRO NITRILE EXAM GLOVE POLYMER PATIENT EXAMINATION GLOVE LZA BOSMA INDUSTRIES FOR THE BLIND, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown