BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT

    MDR report key: 11905900 · Received May 30, 2021

    Report

    Report Number
    2210968-2021-05088
    Event Type
    Injury
    Date Received
    May 30, 2021
    Date of Event
    May 9, 2014
    Report Date
    May 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INT UROGYNECOL J (2014) 25:1269¿1275; DOI 10.1007/S00192-014-2400-3.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: DOES CONCOMITANT ANTERIOR/APICAL REPAIR DURING MIDURETERAL SLING IMPROVE THE OVERACTIVE BLADDER COMPONENT OF MIXED INCONTINENCE? THIS STUDY HYPOTHESIZED THAT WOMEN WITH MIXED URINARY INCONTINENCE (MUI) EXPERIENCE GREATER IMPROVEMENT IN THE OVERACTIVE BLADDER (OAB) COMPONENT OF THEIR SYMPTOMS AFTER CONCOMITANT MIDURETERAL SLING (MUS) AND ANTERIOR/APICAL REPAIR COMPARED WITH MUS ALONE. FROM FEBRUARY 2011 THROUGH DECEMBER 2012, 151 WOMEN WITH BOTHERSOME MUI (PRESENCE OF BOTH STRESS URINARY INCONTINENCE AND OAB) UNDERGOING MUS WERE INCLUDED IN THE STUDY. THERE WERE 67 PATIENTS (MEAN AGE OF 58+/-13 YEARS) WHO UNDERWENT MUS-ONLY AND 84 PATIENTS (MEAN AGE OF 63+/-11 YEARS) UNDERWENT MUS + AA. ALL MUS PROCEDURES WERE PERFORMED USING THE SAME VAGINAL ¿BOTTOM UP¿ RETROPUBIC APPROACH WITH ONE OF 2 KITS AS DESCRIBED BY THE MANUFACTURERS (GYNECARE TVT EXACT (ETHICON) OR A COMPETITOR'S DEVICE) TO ACHIEVE ¿TENSION-FREE¿ PLACEMENT. THE PRIMARY OUTCOME WAS OVERACTIVE BLADDER QUESTIONNAIRE SYMPTOM SEVERITY (OAB-Q SS) CHANGE SCORE ASSESSED AT 6 WEEKS POSTOPERATIVELY; A POSITIVE SCORE INDICATES LESSER SYMPTOM SEVERITY AFTER SURGERY. SECONDARY OUTCOMES WERE THE OAB-Q HEALTH-RELATED QUALITY OF LIFE (HRQL) CHANGE SCORE AND THE URINARY DISTRESS INVENTORY (UDI-6) CHANGE SCORE IN WHICH A NEGATIVE OAB-Q HRQL CHANGE SCORE INDICATES IMPROVED QUALITY OF LIFE AFTER SURGERY, WHILE A POSITIVE UDI-6 CHANGE SCORE INDICATES IMPROVEMENT OR DECREASED SYMPTOM BOTHER. COMPLICATIONS INCLUDED URINARY TRACT INFECTIONS (N=22), URINARY RETENTION (N=8), URGENCY OR IRRITATIVE SYMPTOMS (N=2), FEVER (N=3), HEMATOMA (N=3), PAIN (N=3), AND MESH EROSION (N=2). IN CONCLUSION, OUR RESULTS INDICATE THAT IN WOMEN WITH BOTHERSOME MUI, MUS RESULTS IN SUBJECTIVE IMPROVEMENT IN OAB SYMPTOMS WITHIN 6 WEEKS OF SURGERY. CONCOMITANT ANTERIOR/ APICAL REPAIR DOES NOT RESULT IN ADDITIONAL IMPROVEMENT IN OAB SYMPTOMS OVER MUS ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802198 TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention