BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 10025732 · Received May 5, 2020

    Report

    Report Number
    2210968-2020-03719
    Event Type
    Injury
    Date Received
    May 5, 2020
    Report Date
    April 17, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 05/07/2020. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER FOR EACH PATIENT? - THE CASES DISCUSSED IN THE ARTICLE WERE NOT REPORTED TO ETHICON AS THE AUTHORS DID NOT BELIEVE THE PRODUCT CAUSED THE COMPLICATIONS. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (TVT) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? - THE AUTHORS DID NOT BELIEVE THE PRODUCT CAUSED THE COMPLICATIONS. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (TVT) INVOLVED? - WE DID AND STILL DO NOT BELIEVE A DEFICIENCY WITH THE PRODUCT WAS INVOLVED. PATIENT DEMOGRAPHICS? - WE ARE NOT ALLOWED TO PROVIDE PATIENTS' DATA (PRIVACY LAW).

    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 CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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 FOR EACH PATIENT? DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (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 (TVT) INVOLVED? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE JOURNAL OF UROLOGY, MARCH 2020, 203, 598-603. (B)(4).

    Description of Event or Problem · 1

    TITLE: THE USE OF A VAGINAL PESSARY TO DECIDE WHETHER A MID URETHRAL SLING SHOULD BE ADDED TO PROLAPSE SURGERY THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO DETERMINE WHETHER A VAGINAL PESSARY IS A USEFUL TOOL TO HELP DECIDE WHETHER A MID-URETHRAL SLING (MUS) SHOULD BE ADDED TO PROLAPSE SURGERY. BETWEEN JANUARY 1, 2008 AND DECEMBER 31, 2017, A TOTAL OF 220 WOMEN (MEAN AGE: 67 YEARS, AGE RANGE: 29-94 YEARS) WERE INCLUDED IN THE FINAL STUDY GROUP. WOMEN WITH UNDERLYING BOTHERSOME OCCULT STRESS URINARY INCONTINENCE (SUI) WERE TREATED WITH GYNECARE TVT TENSION-FREE VAGINAL TAPE (ETHICON) (N=65). COMPLAINTS INCLUDED URINARY RETENTION OR VOIDING DYSFUNCTION (N=6), BLADDER PERFORATION (N=1) HEMATOMA IN RETZIUS SPACE (N=1), HEMATOMA IN VAGINAL VAULT (N=1), SLING EROSION (N=1), DYSPAREUNIA OR PERINEAL PAIN (N=1). ALSO, THREE OF THE 65 WOMEN STILL EXPERIENCED URINE LEAKAGE UPON EFFORT POSTOPERATIVELY BUT THEY DID NOT FIND IT INCONVENIENT AND REQUIRED NO FURTHER TREATMENT. ONE OF THE 3 INCONTINENT WOMEN WHO DID NOT RECEIVE AN ADDITIONAL MUS NO LONGER HAD SUI SYMPTOMS. THE 2 OTHER WOMEN STILL HAD UNACCEPTABLE SUI, INCLUDING 1 TREATED WITH PFMT AND 1 WHO UNDERWENT A DELAYED MUS PROCEDURE. ANOTHER WAS REHOSPITALIZED (N=1) TO CUT THE SLING TRANSVAGINALLY DESPITE CLEAN INTERMITTENT SELF-CATHETERIZATION. IN CONCLUSION, IN WOMEN WITH SYMPTOMATIC PELVIC ORGAN PROLAPSE A PESSARY IS A USEFUL TOOL WHEN DECIDING WHETHER TO ADD A MID-URETHRAL SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487653 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention