BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOPCL

    MDR report key: 3370549 · Received September 23, 2013

    Report

    Report Number
    MW5032006
    Event Type
    Injury
    Date Received
    September 23, 2013
    Date of Event
    May 29, 2013
    Report Date
    September 19, 2013
    Manufacturer
    CL MEDICAL INC
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TH CL MEDICAL INC I-STOP TVM HAD TO BE REMOVED DUE TO EROSION, SCARS AND ORGAN PERFORATION. IT WAS PERFORATING THE VAGINA WALL. 3 SURGERIES. FIRST SURGERY 2007 FAILED. ADVISED MD WHO PRACTICALLY IGNORED MY SYMPTOMS AND GAVE A HORMONAL VAGINAL CREAM. SECOND SURGERY, 2013, REMOVAL OF THE I-STOP DUE TO PAIN, BLEEDING, INFECTION AND UNABLE TO HAVE A NORMAL MARITAL RELATIONSHIP WITH MY SPOUSE. THIRD SURGERY 2013 VAGINAL INCISION RUPTURE SHOWING MUSCLE MASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479491 I-STOPCL I-STOPCL OTN CL MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| O| R| S