BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK IVS TUNNELLER DEVICE

    MDR report key: 2953854 · Received January 31, 2013

    Report

    Report Number
    6000141-2013-00015
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    June 10, 2005
    Report Date
    January 7, 2013
    Manufacturer
    BALLMONEY - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT HAS COMPLAINED OF VAGINAL PRESSURE AND/OR PAIN, VAGINAL BLEEDING, DYSPAREUNIA, RECURRENT INFECTIONS, EROSION OF MESH THROUGH HER VAGINAL TISSUE AND/OR INCONTINENCE.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED,URINARY TRACT INFECTIONS AND PAIN,LOWER ABDOMINAL PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE WITH ODOR AND FREQUENCY- 1; INCH OF SLING REMOVED IN OFFICE.VAGINAL BLEEDING, SLIGHT CRAMPING, LIGHT VAGINAL SPOTTING, VAGINAL DISCHARGE, GRANULATION TISSUE AND DRAINING VAGINAL SINUS TRACT STATUS POST SUBURETHRAL SLING. SCHEDULED FOR EXCISION OF BILATERAL VAGINAL SINUS TRACT.UNDERWENT EXCISION OF BILATERAL VAGINAL SINUS TRACT.YES. FOLLOWING THE MESH REVISION SURGERY, SHE DEVELOPED COMPLICATIONS THAT REQUIRED ADDITIONAL MESH REVISION SURGERIES.FOUL SMELLING BLOODY VAGINAL DRAINAGE FROM SINUS TRACT PARAURETHRAL, URINARY URGE INCONTINENCE, NOCTURIA, GRADE 1 CYSTOCELE, GRADE 1 RECTOCELE, WOUND INFECTION, INFECTED BLADDER SLING, INFECTED MESH, URINARY FREQUENCY, URINARY TRACT INFECTION, INFECTED PELVIC ABSCESS, VAGINAL AREA REDNESS, RARE STRESS INCONTINENCE, MUSCLE WEAKNESS AND DRAINAGE. IN-OFFICE CYSTOSCOPY ON (B)(6) 2009 SHOWS THERE WERE NO STONES OR TUMORS SEEN, URETERAL ORIFICES WERE NORMAL IN APPEARANCE AND LOCATION, THERE IS NORMAL FILLING OF THE CONTOURS OF THE BLADDER AND THERE IS NO ERYTHEMA. BLADDER SCAN SHOWS 82 CC. A UROFLOW ON (B)(6) 2009 SHOWED A 20-30 CM H2O PRESSURE DETRUSOR CONTRACTION.HAD PHYSICAL THERAPY TREATMENT FOR SOME DIFFICULTY WITH WOUND HEALING AND INFECTION RECOMMENDED HOME EXERCISE PROGRAM SUPINE QUICK KEGEL CONTRACTIONS. OUTCOME: SHE HAS BEEN ABLE TO RESUME STRESS INCONTINENCE (SI) ACTIVITY WITHOUT PAIN. WOUND HEALING WITH HYPERBARIC TREATMENTS. SHE UNDERWENT ADDITIONAL MESH REVISION SURGERIES AS FOLLOWS:UNDERWENT EXPLORATION OF BILATERAL VAGINAL SINUSES, DEBRIDEMENT OF TISSUE, ANTIBIOTIC IRRIGATION AND CYSTOSCOPY.UNDERWENT TRANSABDOMINAL TRANSVAGINAL COMBINED REMOVAL OF INFECTED TRANSVAGINAL TAPED SLING.DESPITE VARIOUS ATTEMPTS OF SURGICAL CORRECTIONS, SHE CONTINUED TO SUFFER FROM MINIMAL URGE INCONTINENCE, VAGINAL DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42038 UNK IVS TUNNELLER DEVICE IVS TUNNELLER FTL BALLMONEY - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other