BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 537846 · Received August 6, 2004

    Report

    Report Number
    2210968-2004-00427
    Event Type
    Injury
    Date Received
    August 6, 2004
    Report Date
    July 7, 2004
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON CO
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A JOURNAL ARTICLE (UROLOGY (UNITED STATES) 6/2001, 63 (6) P1184-4, ISSN 1527-9995) JOURNAL CODE 0366151) DESCRIBES THE FOLLOWING TVT EVENT: A PT WITH STRESS URINARY INCONTINENCE AND UTERINE PROLAPSE UNDERWENT VAGINAL HYSTERECTOMY FOLLOWED BY TENSION-FREE VAGINAL TAPE (TVT) PLACEMENT. POSTOPERATIVELY, THEY PRESENTED WITH LOW-GRADE FEVER AND ABDOMINAL DISTENSION. ABDOMINAL COMPUTED TOMOGRAPHY REVEALED BOWEL DISTENSION AND ABRUPT CUTTOFF OF THE DISTENDED SMALL BOWEL AND NORMAL BOWEL CALIBER. TRANSPERITONEAL LAPAROTOMY DEMONSTRATED PERFORATION OF THE MESENTERY BY THE TVT WITHOUT OTHER INJURY. THE TAPE WAS CUT IN ITS INTRAPERITONEAL PORTION. THE PT RESUMED NORMAL BOWEL FUNCTION AND, AT LAST FOLLOW-UP, REMAINED CONTINENT."

    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 73 YR Required Intervention