BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMEEX SYSTEM SISTEMA

    MDR report key: 2587598 · Received May 15, 2012

    Report

    Report Number
    2587598
    Event Type
    Injury
    Date Received
    May 15, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 15, 2012
    Manufacturer
    NEOMEDIC INTERNATIONAL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A REMEEX SYSTEM IMPLANTED IN LATE 2007 FOR STRESS URINARY INCONTINENCE, NOCTURIA, FREQUENCY AND STAGE 2 RECTOCELE. PATIENT HAD 2 PREVIOUS BLADDER SURGERIES (1 WAS A BLADDER SLING). PATIENT RECENTLY PRESENTED TO DOCTOR WITH ONGOING VAGINAL PAIN AND LOWER ABDOMINAL TENDERNESS. THE PAIN HAS BEEN PRESENT FOR 2 YEARS AT THE SITE OF THE SUBCUTANEOUS BOX AND BECAME WORSE OVER THE PAST 4-6 MONTHS. PATIENT ALSO REPORTS THE BOX HAS MOVED OUT OF ITS ORIGINAL POSITION. SHE HAS RARE STRESS LEAKAGE, USUALLY WITH SNEEZING WHEN SHE HAS A FULL BLADDER. PATIENT HAD REMOVAL OF REMEEX CONTROLLER BOX AND MID URETHRAL SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMEEX SYSTEM SISTEMA REMEEX SYSTEM FTL NEOMEDIC INTERNATIONAL SREM01 SREM01 34-009 0507

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R