BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL MESH FOR PELVIC PROLAPSE

    MDR report key: 1210943 · Received October 23, 2008

    Report

    Report Number
    MW5008747
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    January 15, 2007
    Report Date
    October 23, 2008
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A PT WHO WAS THE RECIPIENT OF SURGICAL MESH TO REPAIR A VAGINAL, BLADDER AND RECTUM PROLAPSE. I DEVELOPED TWO SEPARATE INFECTIONS AFTER THE SURGERY, VAGINAL AND URINARY. WITHIN A YEARS TIME, THE SURGERY FAILED AND I AM CURRENTLY LIVING WITH ANOTHER PROLAPSE OF SOME SORT PROTRUDING THROUGH MY VAGINA. I DO NOT WANT TO RETURN TO MY DOCTOR OR SPECIALIST BECAUSE I AM NOT HAPPY ABOUT GOING THROUGH AN ADDITIONAL SURGERY AT THIS TIME. I HAVE HAD PAIN DURING INTERCOURSE, URINARY URGENCY, FREQUENT URINATION, BOWEL INCONTINENCE AND BOWEL URGENCY. I DO NOT KNOW IF THE FAILURE OF THE SURGERY AND SUBSEQUENT MEDICAL ISSUES ARE DUE TO THE MESH OR NOT. I AM AFRAID TO GO BACK TO THE DOCTOR AT THIS POINT, AND AM UPSET AND ANGRY AT THE OUTCOME OF MY SURGERY. I JUST DON'T KNOW WHAT TO DO AT THIS POINT, BUT FELT OBLIGATED TO REPORT MY NEGATIVE RESULTS WITH THE FDA IN HOPES THAT OTHER WOMEN CAN BE HELPED. SURGICAL MESH TO TREAT PELVIC PROLAPSE 2007 -APPROX- ALL MEDICAL DATA IS ON FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL MESH FOR PELVIC PROLAPSE FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other