BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITIGEAR STERILE NITRILE EXAMINATION GLOVES

    MDR report key: 24754202 · Received April 1, 2026

    Report

    Report Number
    MW5186220
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 19, 2026
    Report Date
    March 27, 2026
    Manufacturer
    CONTEC, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE DONNING STERILE GLOVES FOR CHEMOTHERAPY PREPARATION, 3 OUT OF 5 PAIRS OF GLOVES TORE DURING THE PROCESS. ONLY ONE PAIR OF GLOVES WAS SAVED FOR REPORTING BUT THEY WERE ALL FROM THE SAME LOT. REFER TO ADD'L DOCUMENTS IN I2K. PT CODE: 4582. DEVICE CODE: 4008. REF REPORTS: MW5186218, MW5186219.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811611 CRITIGEAR STERILE NITRILE EXAMINATION GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA CONTEC, INC. CGN82/FKTPXXL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown