BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMEEX SYSTEM FOR URINARY INCONTINENCE

    MDR report key: 2620791 · Received June 8, 2012

    Report

    Report Number
    3006621295-2012-00002
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    April 23, 2012
    Report Date
    June 6, 2012
    Manufacturer
    DIMA S.L.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED TO THE INITIAL REPORTER (B)(6). DUE TO HOSPITAL POLICIES AND REGULATIONS, SHE IS UNABLE TO ANSWER ANY OF THE QUESTIONS - INCLUDING SUPPLYING THE SURGEON'S INFORMATION OR ANY INFORMATION PT RELATED. SHE TOLD US SHE WILL SEND US THE PROSTHESIS TO ANALYZE IT. TO THE QUESTION REGARDING THE HEALTH OF THE PT, SHE DID SAY THE PT IS DOING OK.

    Description of Event or Problem · 1

    PT HAD A REMEEX SYSTEM IMPLANTED IN LATE 2007 FOR STRESS URINARY INCONTINENCE, NOCTURIA, FREQUENCY AND STAGE 2 RECTOCELE. PT HAD 2 PREVIOUS BLADDER SURGERIES (1 WAS A BLADDER SLING). PT 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. PT 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. PT HAD REMOVAL OF REMEEX CONTROLLER BOX AND MID URETHRAL SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMEEX SYSTEM FOR URINARY INCONTINENCE VAGINAL SLING FTL DIMA S.L. SREM01 34-009 0507

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R POSTERIOR COLPORRHAPHY - RECTOCELE REPAIR| CYSTOSCOPY