BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 138497 · Received December 17, 1997

    Report

    Report Number
    MW1012668
    Event Type
    Malfunction
    Date Received
    December 17, 1997
    Report Date
    July 11, 1997
    Manufacturer
    MONARCH MOLDING INC.
    Product Code
    HIB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VAGINAL SPECULUMS ONCE INSERTED IN THE PT AND LOCKED IN PLACE, CANNOT BE RELEASED. THE LOCKING MECHANISM BECOMES STUCK, PREVENTING THE PROVIDERS FROM RELEASING THE LOCKING MECHANISM TO REMOVE THE SPECULUM AFTER THE PROCEDURE IS COMPLETED. IT HAS TAKEN UP TO FIVE MINS JUST TO RELEASE THE LOCKING MECHANISM ON THE SPECULUM, CAUSING THE PT UNNECESSARY DISCOMFORT AND ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SPECULUM, VAGINAL, PEDERSON TYPE, SMALL, 25S. HIB MONARCH MOLDING INC. 28625 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other