BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7941139 · Received October 5, 2018

    Report

    Report Number
    2210968-2018-76361
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT ( TENSION FREE VAGINAL TAPE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? PLEASE CONFIRM THE SPECIFIC NUMBER OF PATIENTS WHO ENCOUNTERED TAPE EXPOSURES AND EXTRUSIONS. CITATION: INT UROGYNECOL J. 2016; 27: 565¿570. DOI: 10.1007/S00192-015-2853-Z. (B)(4).

    Description of Event or Problem · 1

    TITLE : THE LEARNING CURVE FOR RETROPUBIC MID-URETHRAL SLING. PROCEDURES: A RETROSPECTIVE COHORT STUDY. THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO DETERMINE THE ¿LEARNING CURVE¿ FOR RETROPUBIC MID-URETHRAL SLING PROCEDURES AS JUDGED BY THE RATE OF BLADDER PERFORATION DURING SURGERY; OPERATING TIMES, VOIDING DIFFICULTIES, TAPE EXTRUSIONS AND THE PATIENT¿S PERCEPTION OF OUTCOME WERE EXAMINED AS SECONDARY OUTCOMES. THIS WAS A RETROSPECTIVE SINGLE-CENTRE DATABASE AND CASE NOTE REVIEW OF RETROPUBIC MID-URETHRAL TAPE PROCEDURES. A TOTAL OF 1568 WOMEN WERE IDENTIFIED AS HAVING MID-URETHRAL TAPE PROCEDURES. THE AUTHORS RETROSPECTIVELY EXAMINED THE OUTCOMES OF ALL WOMEN WHO UNDERWENT RETROPUBIC MID-URETHRAL TAPE INSERTION USING GYNECARE TVT (ETHICON) PERFORMED BY A SINGLE CONSULTANT TEAM BETWEEN APRIL 1997 AND DECEMBER 2013. REPORTED COMPLICATIONS INCLUDED TAPE EXPOSURES AND EXTRUSION (6%), URINARY TRACT INFECTION (N-8), DYSPAREUNIA (N-11). THE MID-URETHRAL TAPE PROCEDURE IS SIMPLE IN CONCEPT, AND IS OFTEN LOOKED UPON AS SIMPLE TO LEARN. HOWEVER, THE INHERENTLY ¿BLIND¿ NATURE OF THE PROCEDURES MAKES THEM DIFFICULT TO TEACH, AND THE ¿LEARNING CURVE¿ TO THE POINT OF BEING CAPABLE OF INDEPENDENT PRACTICE MAY BE LONGER THAN PREVIOUSLY CONSIDERED. WHILST SEDUCTIVELY SIMPLE IN CONCEPT, MIDURETERAL TAPE PROCEDURES ARE NOT WITHOUT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781871 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention