BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT DEVICE W/BLUE MESH 3 PK

    MDR report key: 20352862 · Received October 2, 2024

    Report

    Report Number
    2210968-2024-10485
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: CLIN. EXP. OBSTET. GYNECOL. 2024, 51(9), 201.

    Description of Event or Problem · 0

    TITLE: CLINICAL OUTCOMES OF MID-URETHRAL SLING PROCEDURES FOR THE TREATMENT OF FEMALE URINARY INCONTINENCE: A RETROSPECTIVE COHORT STUDY. THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO INVESTIGATE PREDICTIVE FACTORS FOR INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS. BETWEEN FEBRUARY 2016 TO OCTOBER 2022, A TOTAL OF 166 WOMEN WHO UNDERWENT MID-URETHRAL SLING (MUS) PROCEDURES WERE INCLUDED IN THE STUDY. AMONG THEM, 61% (N = 102) UNDERGOING RETROPUBIC TVT AND 39% (N = 64) UNDERGOING TOT SURGERIES. THE IMPLANT USED IN ALL RETROPUBIC PROCEDURES WAS THE POLYPROPYLENE GYNECARE TVT EXACT® CONTINENCE SYSTEM (830041B, ETHICON, BRIDGEWATER, NJ, USA) WHEREAS THE GYNECARE TVT¿ OBTURATOR SYSTEM (810081L, ETHICON, BRIDGEWATER, NJ, USA) WAS USED FOR THE TRANSOBTURATOR ROUTE. REPORTED COMPLICATIONS IN TVT GROUP INCLUDE INTRAOPERATIVE BLADDER/URETHRAL PERFORATION (N=9.8%) AND EARLY POSTOPERATIVE COMPLICATIONS INCLUDING URINARY RETENTION (N=10.8%). WHILE TOT GROUP INCLUDE EARLY POSTOPERATIVE COMPLICATIONS INCLUDING URINARY RETENTION (N=12.5%). IN CONCLUSION, BOTH RETROPUBIC AND TRANSOBTURATOR MUS TECHNIQUES ARE EFFECTIVE FOR MANAGING SUI, WITH THE TRANSOBTURATOR APPROACH SHOWING FEWER COMPLICATIONS AND SHORTER RECOVERY TIMES. WE RECOMMEND THE FORMATION OF A NATIONAL REGISTRY TO TRACK LONG-TERM OUTCOMES AND ENHANCE PROCEDURAL EVIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35755 TVT DEVICE W/BLUE MESH 3 PK MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other