BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 8214872 · Received January 3, 2019

    Report

    Report Number
    2210968-2019-78157
    Event Type
    Injury
    Date Received
    January 3, 2019
    Report Date
    December 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: CHONNAM MED J 2011; 47: 165-169. DOI: TTP://DX.DOI.ORG/10.4068/CMJ.2011.47.3.165 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : COMPLICATIONS FOLLOWING OUTSIDE-IN AND INSIDE-OUT TRANSOBTURATOR-TAPE PROCEDURES WITH CONCOMITANT GYNECOLOGIC OPERATIONS" AUTHOR: MOON KYOUNG CHO, CHUL HONG KIM*, WOO DAE KANG, JONG WOON KIM, SEOK MO KIM AND YOON HA KIM CITATION: CHONNAM MED J 2011; 47: 165-169. DOI: TTP://DX.DOI.ORG/10.4068/CMJ.2011.47.3.165. THIS STUDY WAS UNDERTAKEN TO COMPARE THE COMPLICATIONS OF OUTSIDE-IN TRANSOBTURATOR TAPE PROCEDURES (TOT) AND INSIDE-OUT TRANSOBTURATOR TAPE PROCEDURES (TVT-O) WITH CONCOMITANT GYNECOLOGIC SURGERY FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI). A RETROSPECTIVE REVIEW OF 206 CONSECUTIVE PATIENTS WHO UNDERWENT EITHER TOT OR TVT-O WITH CONCOMITANT GYNECOLOGIC OPERATIONS BETWEEN MARCH 2008 AND FEBRUARY 2011 WAS CONDUCTED. OF WHICH, 145 PATIENTS (AGE: 51.26 ± 8.30) UNDERWENT TOT AND 61 PATIENTS (AGE: 53.38 ± 8.50) UNDERWENT TVT-O PROCEDURES. IN THE TVT-O GROUP, THE PROCEDURE WAS PERFORMED USING GYNECARE TVT-O TAPE (ETHICON). IN THE TVT-O GROUP, REPORTED COMPLICATIONS INCLUDED URINARY RETENTION (N-2) WHICH REQUIRED URETHRAL CATHETER, URINARY TRACT INFECTION (N-2) WHICH RESOLVED AFTER ANTIBIOTIC TREATMENT, DE NOVO URGENCY (N-1) WHICH WERE TREATED WITH ANTI-CHOLINERGIC MEDICATION AND THEIR SYMPTOMS WERE RESOLVED WITHIN 1 TO 2 MONTHS, AND DYSPAREUNIA (N-1). IN SUMMARY, THE RESULTS OF THE STUDY SHOW THAT THE COMPLICATION RATES OF THE TVT-O AND TOT WITH CONCOMITANT GYNECOLOGIC OPERATION WERE SIMILAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6821 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention