BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITIGEAR STERILE NITRILE EXAMINATION GLOVES

    MDR report key: 21900214 · Received April 24, 2025

    Report

    Report Number
    MW5169488
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 18, 2025
    Report Date
    April 21, 2025
    Manufacturer
    CONTEC, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TECHNICIAN FOUND A SIZE MEDIUM PAIR OF CRITIGEAR STERILE NITRILE EXAMINATION GLOVES WITH A GREASY RESIDUE LIGHT CONTAMINATION ON BOTH GLOVES. LOT CGN82/FKTPM 9600006-3, BATCH N820424, PREP DATE (B)(6) 2024, EXP 01/11/2029. GLOVES WERE NOT USED FOR COMPOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226325 CRITIGEAR STERILE NITRILE EXAMINATION GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA CONTEC, INC. CGN82/FKTPM 960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown