BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE CONTEC GLOVES

    MDR report key: 20598808 · Received November 1, 2024

    Report

    Report Number
    MW5162090
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 21, 2024
    Report Date
    October 30, 2024
    Manufacturer
    CONTEC INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOUR (4) PAIRS OF STERILE CONTEC GLOVES FOUND WITH BLACK SPECKS AND 1 HAD A PIECE OF TAP ON THE GLOVE. LOT NUMBERS ARE BELOW: CGN82/FKTPM 9600001-7 CGN80/FKTPM9600012-9. REFERENCE REPORTS MW5162087, MW5162088, MW5162089.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598458 STERILE CONTEC GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA CONTEC INC. CGN80/FKTPM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other