BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP TRANSVAGINAL MESH / SLING

    MDR report key: 9575628 · Received January 9, 2020

    Report

    Report Number
    MW5092151
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    April 28, 2014
    Report Date
    January 7, 2020
    Manufacturer
    CL MEDICAL INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2014, AT THE RECOMMENDATION OF MY UROGYNECOLOGIST, I HAD THE I-STOP TRANS-VAGINAL MESH/SLING IMPLANTED TO CORRECT MY VAGINAL PROLAPSE. HOWEVER, AFTER THE IMPLANTATION OF THE DEVICE I BEGAN HAVING CONTINUOUS, OFTEN PAINFUL INFECTIONS THAT REQUIRED ANTIBIOTICS FROM THE DR AND SOMETIMES A VISIT TO THE HOSP WHEN THE INFECTION STARTED CAUSING SEVERE CRAMPING. AFTER THE IMPLANTATION, I DEVELOPED URINE AND BOWEL INCONTINENCE AS WELL AS FREQUENT CONSTIPATION. WHEN I WOULD TRY TO RELIEVE THE CONSTIPATION WITH WHATEVER THE DR RECOMMENDED, I WOULD OFTEN EXPERIENCE THE BOWEL INCONTINENCE. IT WOULD HAPPEN ANYWHERE, AT ANYTIME AND WITHOUT WARNING. DO YOU HAVE A PICTURE OF THE PRODUCT? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30291 I-STOP TRANSVAGINAL MESH / SLING MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE OTN CL MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R