BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTEC STERILE GLOVES

    MDR report key: 19342215 · Received May 16, 2024

    Report

    Report Number
    MW5155073
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 14, 2024
    Manufacturer
    CONTEC, INC.
    Product Code
    LZC
    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

    PHARMACY TECHNICIAN FOUND YELLOW DISCOLORING ON STERILE GLOVES IN THE IV(INTRAVENOUS) ROOM. CONTEC STERILE GLOVES, LOT NO: CGN80/FKTPS 9600009-6 BATCH NO: N800422.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616028 CONTEC STERILE GLOVES MEDICAL GLOVE, SPECIALTY LZC CONTEC, INC. HCGS0012 CGN80/FKTPS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown