BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP TRANSVAGINAL MESH

    MDR report key: 2822842 · Received October 26, 2012

    Report

    Report Number
    MW5027480
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    January 1, 2007
    Report Date
    October 26, 2012
    Manufacturer
    CL MEDICAL INC. RIVERVIEW II
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE I-STOP TRANSVAGINAL MESH FROM CL MEDICAL WAS GRANTED A 501K BECAUSE THEY STATED THAT THE MESH IS EQUIVALENT TO THE ETHICON TRANSVAGINAL MESH FOR THE CORRECTION OF UTI. NOT TRUE. THIS HAS CAUSED ME MANY PROBLEMS, INCLUDING THE NEED FOR MORE SURGERY BECAUSE THE MESH INSTEAD OF HELPING THE INCONTINENCE MADE IT WORST AFTER 3 MONTHS OF SURGERY. I RETURNED TO THE ORIGINAL SURGEON 10 MONTHS AFTER SURGERY. I HAD BLOOD IN THE URINE, THE STRESS INCONTINENCE WAS WORST. HE GAVE ME A HORMONAL CREAM, WHICH DID NOT WORK. I'VE BEEN ADVISED THAT THE DAMAGE IS IRREVERSIBLE. THE SECOND SURGERY IS MORE DIFFICULT THAN THE FIRST AND IT HAS A GREATER CHANCE TO FAIL. MY LIFE IS IN DANGER SINCE I HAVE SENSITIVITY TO SOME ANESTHESIA, LIKE SUCCINYL CHOLINE. THIS MESH IS GIVING ME UNBEARABLE PELVIC AND VAGINAL PAIN. MY MARRIAGE IS FAILING DUE TO OBVIOUS REASONS. I NO LONGER ENJOY LIFE, NO LONGER CAN EXERCISE, NO LONGER CAN GO TO THE PARK AND ENJOY MY CHILDREN, NO LONGER COUGH, NO LONGER LAUGH, NO LONGER LEAD A NORMAL LIFE THANKS TO THE I-STOP MESH FROM CL MEDICAL. I AM UPSET AND I FEEL AWFUL ABOUT MYSELF. I HAVE TO WEAR DEPENDS AT THIS EARLY AGE. PLEASE HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STOP TRANSVAGINAL MESH TRANSVAGINAL MESH OR TRANSVAGINAL SLING FTL CL MEDICAL INC. RIVERVIEW II

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| O| S I-STOP SOLUTION| I-STOP TRANSVAGINAL MESH| I-STOP TRANSVAGINAL SLING