BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7967159 · Received October 15, 2018

    Report

    Report Number
    2210968-2018-76541
    Event Type
    Injury
    Date Received
    October 15, 2018
    Report Date
    September 20, 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. 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 ( GYNECARE TVT) 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 ( GYNECARE TVT) INVOLVED? PLEASE CONFIRM IN WHAT SPECIFIC PROCEDURAL GROUP DOES THE EVENT OF VOIDING DYSFUNCTION (N-2) OCCURRED. CITATION: INT UROGYNECOL J. 2016; 27: 923¿931. DOI: 10.1007/S00192-015-2912-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: RISK FACTORS FOR FAILURE OF REPEAT MIDURETHRAL SLING SURGERY FOR RECURRENT OR PERSISTENT STRESS URINARY INCONTINENCE" AUTHOR: TSIA-SHU LO, LENG BOI PUE, YIAP LOONG TAN, PEI-YING WU CITATION: INT UROGYNECOL J. 2016; 27: 923¿931. DOI: 10.1007/S00192-015-2912-5. THE AUTHORS AIMED TO STUDY THE OUTCOMES OF REPEAT MUS SURGERY IN PATIENTS WITH PERSISTENT OR RECURRENT SUI AFTER FAILURE OF PRIMARY MUS SURGERY AND FACTORS ASSOCIATED WITH FAILURE. A TOTAL OF 24 PATIENTS (AGE: 58.7 ± 11.7 YEARS; BMI: 24.8 ± 3.2) WHO UNDERWENT REPEAT MUS SURGERY AT A SINGLE TERTIARY CENTER FROM JANUARY 2004 TO FEBRUARY 2014 WERE REVIEWED. THE TYPES OF MUS USED FOR THE REPEAT SURGERY WERE TRANSOBTURATOR (TOT), RETROPUBIC (TVT), AND SINGLE INCISION SLINGS. THE PATIENTS WERE OPERATED ON BY ONE OF THE AUTHORS USING THE GYNECARE TVT (ETHICON) SYSTEM. TENSIONING OF THE TAPES FOR GYNECARE TVT (ETHICON) WAS ACHIEVED BY ENSURING THERE WAS SUFFICIENT SPACE TO PLACE A METZENBAUM SCISSORS BETWEEN THE URETHRA AND THE TAPE IN A TENSION-FREE MANNER. IN THE TVT GROUP, REPORTED COMPLICATIONS INCLUDED VOIDING DYSFUNCTION (N-2) WHICH REQUIRED BLADDER CATHETERIZATION FOR 2 DAYS AND BLADDER PERFORATED (N-1) AND WAS SUCCESSFULLY MANAGED CONSERVATIVELY WITH CONTINUOUS BLADDER DRAINAGE FOR 3 DAYS. IT WAS REPORTED THAT A REPEAT TVT SEEMS TO BE THE MOST FAVORED CHOICE AMONG EXPERTS IN THOSE WHO HAVE FAILED PRIMARY TVT AS IT OFFERS BETTER RESULTS THAN A TOT. IT WAS CONCLUDED THAT THE REPEAT MUS SURGERY IS SAFE AND HAS A GOOD SHORT-TERM SUCCESS RATE, BOTH OBJECTIVELY AND SUBJECTIVELY, WITH INDEPENDENT RISKS FOR FAILURE RELATED TO BLADDER NECK HYPOMOBILITY AND POOR URETHRAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808140 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention