BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT

    MDR report key: 7096917 · Received December 7, 2017

    Report

    Report Number
    2210968-2017-71666
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    September 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO: 9/4/2019.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE, ¿MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF PRIMARY STRESS URINARY INCONTINENCE¿ THAT A STUDY WAS CONDUCTED TO EVALUATE THE EFFICACY AND MORBIDITY OF THE NEW MINIMALLY INVASIVE MESH PROCEDURE IN THE TREATMENT OF PRIMARY STRESS URINARY INCONTINENCE (SUI). THE STUDY DESIGN WAS A PROSPECTIVE MULTI-CENTRE TRIAL INVOLVING 4 DIFFERENT HOSPITALS. ALL PATIENTS WITH PRIMARY URODYNAMIC SUI AND URETHRAL HYPERMOBILITY WERE PROSPECTIVELY SELECTED TO RECEIVE THE PROCEDURE. EACH CENTRE WAS ALLOWED TO PERFORM THE PROCEDURE EITHER IN THE ¿HAMMOCK¿- OR ¿U¿-SHAPED APPROACH. FROM NOVEMBER 2006 TO SEPTEMBER 2007, 95 CONSECUTIVE PATIENTS (MEAN AGE 57+/-10 YEARS [RANGE 36-79]; MEDIAN PARITY 2 [RANGE 0-6]; MEDIAN BMI 27.1+/-5 KG/M2) WERE ENROLLED IN THE STUDY. POSTOPERATIVE COMPLICATIONS INCLUDE: VOIDING DIFFICULTY (N=7), RECURRENT URINARY TRACT INFECTION (N=9), DE NOVO URGENCY INCONTINENCE (N=9), DYSPAREUNIA FOR A DEFECT HEALING WITH VAGINAL PROTRUSION OF THE MESH (N=2). THE TVT-SECUR PROCEDURE SEEMS TO BE AN EFFECTIVE TREATMENT FOR WOMEN WITH PRIMARY SUI WITH AN OVERALL SUCCESS RATE OF 80%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874002 TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL PAH ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1