BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 25056124 · Received May 1, 2026

    Report

    Report Number
    2954762-2026-00001
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 8, 2026
    Manufacturer
    IDEAL QUALITY SDN BHD
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FEMALE DOCTOR CLAIMS THAT THE GLOVES LEFT A CHEMICAL RESIDUE ON HER HANDS AND SKIN/EYES TOUCHED AFTER THE GLOVES WERE REMOVED DESPITE HANDWASHING. THERE WERE SIGNS OF REDNESS, SWELLING AND IRRITATION SHORTLY AFTER USE AND WERE LOCALIZED TO AREAS OF CONTACT. THE GLOVES ARE STORED IN ACCORANCE WITH STANDARD PRACTICE IN CLEAN, TEMPERATURE CONTROLLED ENVIRONMENT. AS A RESULT, THE DOCTOR NEEDED TO SEEK MEDICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623318 HENRY SCHEIN CRITERION N200 GLOVE BLUE NITRILE M 200/BX LZA IDEAL QUALITY SDN BHD K0402611A04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention