BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 416572 · Received September 13, 2002

    Report

    Report Number
    2210968-2002-00820
    Event Type
    Injury
    Date Received
    September 13, 2002
    Report Date
    August 14, 2002
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON CO.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE INT'L UROGYNECOLOGY JOURNAL (2002) 13:263-265, THAT THE PT UNDERWENT A SLING PROCEDURE. THE PREOPERATIVE PHYSICAL EXAMINATION SHOWED A GRADE 1 ANTERIOR VAGINAL WALL DEFECT ACCORDING TO THE HALFWAY SYSTEM CLASSIFICATION AND A HYPERMOBILE URETHRA DIAGNOSED USING THE COTTON SWAB TEST. THE URODYNAMIC EVALUATION SHOWED A STABLE BLADDER WITH A WELL COMPLIANT BLADDER, CONFIRMING THE DIAGNOSIS OF GENIUNE STRESS INCONTINENCE. THE VOIDING PATTERN WAS NORMAL WITH NO RESIDUALS. THE SLING PROCEDURE WAS PERFORMED UNDER EPIDURAL ANESTHESIA. DESPITE THE USE OF EPIDURAL ANESTHESIA, 40 ML OF SALINE SOLUTION WERE INJECTED BILATERALLY INTO THE SPACE OF RETZIUS TO ALLOW A SLIGHT DISSECTION OF THE RETROPUBIC SPACE. THE SLING WAS PLACED. AFTER CYSTOSCOPY, THE TENSION OF THE TAPE WAS ADJUSTED WHILE THE PT WAS COUGHING. THE PROCEDURE WAS UNEVENTFUL. BLOOD LOSS WAS MINIMAL, OPERATING TIME WAS 25 MINS AND THE PT LEFT THE OPERATING THEATRE WITH A 12 FR. FOLEY CATHETER IN THE BLADDER. AFTER ABOUT 3 HRS IN THE WARD, THE PT BEGAN TO SUFFER AN ACUTE LOW ABDOMINAL PAIN RADIATING TO THE EPIGASTRIC REGION. PHYSICAL EXAMINATION SHOWED NO ABNORMAL FINDINGS IN THE PELVIS. THERE WAS NO CONTRACTING REACTION OF THE ABDOMINAL WALL, BUT THE PAIN WAS EXACERBATED BY COMPRESSION OF THE RIGHT ILIAC REGION. THE VITAL SIGNS WERE NORMAL. BODY TEMP WAS NORMAL. INITIAL LAB STUDIES SHOWED A HEMOGLOBIN CONCENTRATION OF 12.2 G/DL AND WHITE CELL COUNT OF 17.4 COMPARED TO PREOPERATIVE VALUES OF 13.2G/DL AND 5.9 RESPECTIVELY. ANALGESICS WERE GIVEN BUT PROVED INEFFECTIVE. PHYSICAL EXAMINATION REVEALED A PERSISTENT POSITIVE BLUMBERG'S SIGN IN THE RIGHT ILIAC REGION. A REPEATED HEMOCHROME SHOWED STABLE HEMOGLOBIN CONCENTRATION OF 12.3 G/DL AND AN INCREASE IN WHITE BLOOD CELLS TO 19.9. A LAPRASCOPY WAS PERFORMED 5 HRS AFTER THE INITIAL PROCEDURE. THE TAPE WAS FOUND PENETRATING IN THE PERITONEUM OF THE PELVIS, WITH A LOOP OF ILEUM BEING TRANSFIXED. THE ILEAL LOOP APPEARED NORMAL WITH NO SIGN OF VASCULAR INJURY. THE TAPE WAS CUT IN ITS INTRAPERITONEAL PORTION, THE ILEUM FREED AND TWO STITCHES WERE PLACED ON EACH SIDE OF THE ILEAL LOOP. THE PT RECOVERED WELL AND WAS DISCHARGED ON THE FIFTH DAY. AT THE 6 AND 12 MO FOLLOW UP VISITS, THE PT WAS DRY AND NO URINARY LEAKAGE WAS DEMONSTRATED DURING THE COUGH PROVOCATION TEST WITH 300 ML OF SALINE SOLUTION IN THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE TVT DEVICE FTL ETHICON SARL A JOHNSON & JOHNSON CO. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention