BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILEX

    MDR report key: 591608 · Received April 14, 2005

    Report

    Report Number
    1216677-2005-00009
    Event Type
    Other
    Date Received
    April 14, 2005
    Date of Event
    October 23, 2004
    Report Date
    April 13, 2005
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FIT WITH A DONUT PESSARY IN 2004. THE PATIENT WAS EXPERIENCING DISCOMFORT WITH THE PESSARY IN PLACE. THE PATIENT RETURNED TO THE PHYSICIAN FEBRUARY 2005. THE PHYSICIAN HAD DIFFICULTY IN REMOVING THE PESSARY. A SYRINGE WAS USED TO REMOVED FLUID THAT HAD BUILT UP BEHIND THE PESSARY. THE PHYSICIAN HAS SCHEDULED SURGERY TO REMOVE THE PESSARY. SURGERY IS SCHEDULED FOR 4/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILEX DONUT PESSARY HHW COOPERSURGICAL, INC. MXPDO *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention