BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM STERILE GLOVES

    MDR report key: 21739968 · Received April 1, 2025

    Report

    Report Number
    MW5168459
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 26, 2025
    Report Date
    March 28, 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

    STERILE COMPOUNDER FOUND HAIR IN A NEW PACKAGE OF CONTEC STERILE GLOVES. CONTAMINATED GLOVES WERE NOT USED IN PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2691897 MEDIUM STERILE GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA CONTEC, INC. CGN82/FKTPM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown