BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITRILE GLOVES

    MDR report key: 22213623 · Received June 16, 2025

    Report

    Report Number
    MW5171510
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 4, 2025
    Manufacturer
    AMMEX CORPORATION
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AMM NITRILE GLOVE FROM RECENTLY OPENED BOX HAD BROWN SUBSTANCE INSIDE THE GLOVE. 202406; EXP: 06/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987618 NITRILE GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA AMMEX CORPORATION 202406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other