BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 12451086 · Received September 9, 2021

    Report

    Report Number
    2210968-2021-08237
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 18, 2018
    Report Date
    November 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 11/05/2021. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 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? PATIENT DEMOGRAPHICS?

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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:HTTPS://DOI.ORG/10.1016/J.JMIG.2018.08.010. ATTEMPTS ARE BEING MADE TO OBTAIN 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. 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? PATIENT DEMOGRAPHICS? ADVERSE EVENTS RELATED TO (B)(6) YEAR-OLD FEMALE PATIENT REPORTED VIA MW # 2210968-2021-08238. ADVERSE EVENTS RELATED TO (B)(6) YEAR-OLD FEMALE PATIENT REPORTED VIA MW # 2210968-2021-08239.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: TENSION-FREE VAGINAL TAPE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE: A 13-YEAR PROSPECTIVE FOLLOW-UP. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE LONG TERM SAFETY AND EFFICACY OF TENSION-FREE VAGINAL TAPE (TVT). IT IS A PROSPECTIVE OBSERVATIONAL STUDY THAT WAS PERFORMED IN THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY AT A TERTIARY REFERRAL HOSPITAL. BETWEEN JANUARY 2004 AND DECEMBER 2005, 85 SUI PATIENTS SCHEDULED FOR TVT PROCEDURES WERE PROSPECTIVELY ENROLLED IN THIS STUDY. THE NEEDLE AND KNITTED POLYPROPYLENE TAPE WERE GYNECARE PRODUCTS (ETHICON, SOMERVILLE, NJ). THE PROCEDURES WERE PERFORMED WITH THE PATIENT IN THE LITHOTOMIC POSITION UNDER GENERAL ANESTHESIA. THE TAPE WAS INSERTED VIA A 1-CM INCISION, 1 CM BELOW THE EXTERNAL URETHRAL MEATUS, AND WAS PASSED THROUGH THE RETROPUBIC SPACE TO EXIT VIA 2 INCISIONS ABOVE THE SYMPHYSIS PUBIS. ADJUSTMENT TO TENSION-FREE WAS PERFORMED USING CURVED SCISSORS. REPORTED COMPLICATIONS INCLUDED DE NOVO OVER ACTIVE BLADDER (N=11), RECURRENT UTI (N=4), TAPE EXPOSURE (N=2), VOIDING CHANGES, SPLITTING OF URINARY STREAM AND MICTURITION (N=12). A (B)(6) YEARS OLD FEMALE PATIENT EXPERIENCED DYSPAREUNIA. A (B)(6) YEARS OLD FEMALE PATIENT EXPERIENCED DYSPAREUNIA. IN CONCLUSION TVT IS A SAFE AND EFFECTIVE TREATMENT FOR STRESS URINARY INCONTINENCE, EVEN AT THE 13-YEAR FOLLOW-UP. THE PREVALENCE RATES OF OVERACTIVE BLADDER AND VOIDING SYMPTOMS ARE INCREASED WITH ADVANCING AGE AND SHOULD NOT BE CONSIDERED LONG-TERM POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348217 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention