BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    MDR report key: 9257811 · Received October 30, 2019

    Report

    Report Number
    2210968-2019-89257
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    October 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGICAL TECHNOL. INTERNATIONAL 23:176¿180 (2016). (B)(4).

    Description of Event or Problem · 1

    TITLE: RETROSPECTIVE ANALYSIS OF THE OUTCOME OF THE TVT -ABBREVO; A ONE YEAR FOLLOW UP STUDY. THIS RETROSPECTIVE STUDY DISCUSSED ABOUT THE OUTCOME OF THE TVT-ABBREVO (ETHICON) AT 1-YEAR FOLLOW-UP. 98 PATIENTS WERE INCLUDED IN THE STUDY AND HAD A FOLLOW-UP AT 8 WEEKS, 6 MONTHS AND 1 YEAR. ALL PATIENTS HAD BLADDER/PRESSURE FLOW STUDY BEFORE THE OPERATION. REPORTED COMPLICATIONS AT 6-8 WEEKS FOLLOW-UP INCLUDED DE NOVO VOIDING DYSFUNCTION (N=23); MAJOR BLEEDING (N=1); PAIN (N=7); EROSION (N=5) COMPLICATIONS AT 6 MONTHS FOLLOW-UP INCLUDED DE NOVO VOIDING DYSFUNCTION (N=5); PAIN (N=7); DYSPAREUNIA (N=7); EROSION (N=6); COMPLICATIONS AT 1 YEAR INCLUDED DE NOVO VOIDING DYSFUNCTION (N=5); GROIN PAIN (N=6); DYSPAREUNIA (N=7) AND EROSION (N=6) IN WHICH THE TAPE NEEDED TO BE REMOVED. IN CONCLUSION, AT 1 YEAR FOLLOW UP, TVT-ABBREVO HAS A COMPARABLE SUCCESS RATE TO THE OTHER SUBURETHERAL SLING PROCEDURES HOWEVER; THERE IS COMPARABLE RISK OF GROIN PAIN AND SLIGHTLY INCREASED RISK EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051594 TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention