BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILEX

    MDR report key: 511115 · Received February 2, 2004

    Report

    Report Number
    MW1031022
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    November 1, 2002
    Report Date
    January 16, 2004
    Manufacturer
    MILEX PRODUCTS, INC. CREATORS OF UNIQUE GYNECK SPECIALTIES
    Product Code
    HHW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FITTED WITH PESSARY FOR PROLAPSED BLADDER. DEVELOPED PERINEAL IRRITATION. LEFT OUT FOR A WHILE, WHEN REINSERTED 2 WEEKS LATER, DEVELOPED THE IRRITATION, CONTINUED TO USE, AND REMOVED AT NIGHT. BEGAN TO DEVELOP JAW PAIN, CONSTIPATION, JOINT PAIN, AND RECTAL BLEEDING FROM CONSTIPATION. ALSO DEVELOPED SOB WITH EXERTION, LEFT LEG PAIN AND BURNING WITH LEFT FOOT DRAGGING. PAIN ALSO DEVELOPED IN RIGHT AND LEFT HIP. BEGAN TO HAVE BODY PUFFINESS AND STIFFNESS, RED RASH OVER TRUNK OF BODY AND HIVES AT NIGHT. RIGHT SHOULDER DEVELOPED SHARP/BURNING PAIN. HANDS SO SWOLLEN, HAD TO HAVE RING REMOVED. HAND PAIN WITH NUMBNESS. ALSO FATIGUE, DIAPHORESIS, NAUSEA, MALAISE, SED RATE ELEVATED. ALSO DEPRESSION FROM ALL THE ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILEX FOLDING RING PESSARY HHW MILEX PRODUCTS, INC. CREATORS OF UNIQUE GYNECK SPECIALTIES CW-RING *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention