BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROLIFT MESH KIT

    MDR report key: 2230382 · Received August 28, 2011

    Report

    Report Number
    MW5021918
    Event Type
    Other
    Date Received
    August 28, 2011
    Date of Event
    July 3, 2007
    Manufacturer
    UNK
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2004, I WAS DIAGNOSED WITH PELVIC PROLAPSE AND CYSTOCELE. PRIOR TO THIS DIAGNOSIS, I HAD BEEN EXPERIENCING MODERATE URINARY TRACT INFECTIONS. IN (B)(6) 2007, I RETURNED TO THE GYNECOLOGIST FOR FURTHER EXAMINATION DUE TO THE NEED FOR CONSISTENTLY EXPERIENCING UTI'S REQUIRING ANTIBIOTICS. ALSO, MY BLADDER HAD DROPPED CAUSING PAIN AND COMPLICATIONS. THE PROCEDURE PERFORMED (B)(6) 2007 WITH USE OF A TOTAL PROLIFT MESH KIT. POST-OP APPEARED TO BE NORMAL AND I WAS FEELING MUCH BETTER BUT CONTINUED TO HAVE UTI'S. ABOUT 2 YRS AFTER SURGERY, I BEGAN HAVING PAIN IN THE LOWER REGION AT THE BLADDER, VARIOUS FORMS OF URINARY LEAKAGE AND/OR LOSS OF URINE ALONG WITH PROGRESSIVE UTI'S. RECTAL PROBLEMS ALSO WERE OCCURRING. FEELING THAT THE BLADDER HAD DROPPED AGAIN, I SAW THE DOCTOR AND SHE SAID I WAS O.K UPON EXAMINATION THIS YEAR. RECENTLY I BEGAN HEARING ABOUT OTHER WOMEN HAVING THE SAME SYMPTOMS, WENT TO THIS WEBSITE AND THEN MADE MY DECISION TO REPORT THIS PROBLEM TO YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT MESH KIT NONE FTL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other