BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 8210637 · Received January 2, 2019

    Report

    Report Number
    2210968-2019-78123
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    December 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: INT UROGYNECOL J (2015) 26:57¿63; DOI 10.1007/S00192-014-2454-2.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: TVT VERSUS LAPAROSCOPIC MESH COLPOSUSPENSION: 5-YEAR FOLLOW-UP RESULTS OF A RANDOMIZED CLINICAL TRIAL". AUTHOR(S): A. VALPAS & S. ALA-NISSILÄ & E. TOMAS & C. G. NILSSON. CITATION: INT UROGYNECOL J (2015) 26:57¿63; DOI 10.1007/S00192-014-2454-2. THE AIM OF THE PRESENT TRIAL WAS TO COMPARE THE NEW MINIMALLY INVASIVE TENSION-FREE VAGINAL TAPE (TVT) PROCEDURE WITH LAPAROSCOPIC MESH COLPOSUSPENSION (LCM). IN A 5-YEAR FOLLOW UP BETWEEN NOV1999 AND AUG2001, 121 FEMALE PATIENTS WITH HISTORY OF STRESS URINARY INCONTINENCE (SUI) UNDERWENT TVT PROCEDURES (N=70; MEAN AGE OF 50 YEARS [RANGE 33-67 YEARS]) AND LCM PROCEDURES (N=51; MEAN OF 48 YEARS [29-68 YEARS]). IN TVT GROUP, TVT KIT, GYNECARE WAS USED. POSTOPERATIVELY IN TVT GROUP, COMPLICATIONS INCLUDED PROTRUSION OF TVT SLING IN THE MIDLINE (N=1) FOR WHICH THE VISIBLE PART WAS EXCISED; PROLAPSE (N=1) FOR WHICH PROLAPSE PROCEDURE WAS PERFORMED; AND PERSISTENT INCONTINENCE (N=1) TREATED WITH BULKING AGENT INJECTION WITH ZUIDEX.. THE RESULTS SUGGEST THAT THE TVT PROCEDURE IS SUPERIOR TO THE LCM EVALUATED BOTH BY THE PER PROTOCOL AND THE INTENTION-TO-TREAT PRINCIPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3140 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention