BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASILK MESH BY COLOPLAST

    MDR report key: 2032615 · Received March 23, 2011

    Report

    Report Number
    MW5019947
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    December 5, 2008
    Report Date
    March 23, 2011
    Manufacturer
    COLOPLAST
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD NOVASILK MESH BY COLOPLAST SURGICALLY PLACED FOR REMEDY OF A PROLAPSED BLADDER. I HAVE VAGINAL BLEEDING, INFECTION, SEVERAL ABSCESSES, AND PROBLEMS WITH AMBULATION THAT STARTED IMMEDIATELY AFTER THE SURGERY. I AM REPORTING THESE THINGS BECAUSE I STILL HAVE NOT COMPLETELY REMEDIED THE PROBLEM THAT I ORIGINALLY SOUGHT TREATMENT FOR. I AM RETURNING TO THE DOCTOR AGAIN IN ORDER TO GET A SOLUTION TO THIS MEDICAL ISSUE. TWO YRS HAVE ELAPSED AND I AM STILL EXPERIENCING THESE DISCOMFORTS. PLEASE BE AWARE OF THESE PROBLEMS AND ADVISE OTHER POTENTIAL PTS/CONSUMERS ABOUT THESE ISSUES. NO ONLY AM I STRUGGLING WITH THE URINARY ISSUES, I HAVE NOW ADDED PAINFUL AMBULATION TO MY COMPLAINTS AS A RESULT OF THIS SURGERY THAT WAS SUPPOSED TO HELP. I HAD NOVASILK MESH IMPLANTED FOR TOTAL PELVIC FLOOR REPAIR. I HAVE EXPERIENCED INFECTIONS, PAIN, BREAK THROUGH VAGINAL BLEEDING, ABSCESSES AND PAINFUL AMBULATION SINCE THE SURGERY. I AM STILL EXPERIENCING THESE SYMPTOMS AND AM RETURNING TO THE DOCTOR TO SEEK REMEDY. THE WIRES USED TO ATTACH THE DEVICE TO MY BODY WERE NOT COVERED ADEQUATELY DUE TO LOW LEVELS OF HORMONES. THIS CAUSED PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASILK MESH BY COLOPLAST TOTAL PELVIC FLOOR REPAIR FTL COLOPLAST

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other