BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 8934729 · Received August 27, 2019

    Report

    Report Number
    2210968-2019-86272
    Event Type
    Injury
    Date Received
    August 27, 2019
    Report Date
    July 31, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. CITATION: J MED ASSOC THAI 2005; 88(1): 5-8. (B)(4).

    Description of Event or Problem · 1

    TITLE: THE THREE YEARS RESULTS OF TENSION FREE VAGINAL TAPE (TVT) FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN THAI WOMEN. THIS STUDY AIMED TO EVALUATE THE 3 YEARS RESULTS OF TVT IN THE TREATMENT OF SUI IN THAI WOMEN. FROM FEBRUARY 2000 TO MAY 2001, 63 THAI WOMEN DIAGNOSED AS HAVING SUI WERE INCLUDED IN THE STUDY. AFTER MINIMAL BILATERAL PARAURETHRAL DISSECTIONS OF THE VAGINAL WALL, A SPECIFIC PROLENE TAPE COVERED BY A PLASTIC SHEATH WAS INTRODUCED USING A TWO-COMPONENT NEEDLE INSTRUMENT. COMPLICATIONS INCLUDED URINARY RETENTION (N=1) WHICH NEEDED CLEAN INTERMITTENT CATHETERIZATION FOR 5 DAYS; DE NOVO DETRUSOR OVERACTIVITY (N=3) WHICH REQUIRED ANTICHOLINERGIC DRUG AND BLADDER TRAINING AND MINIMAL LEAKAGE WHEN STRAINING (N=3). IN CONCLUSION, TVT WAS EFFECTIVE AND SAFE IN THE TREATMENT OF STRESS URINARY INCONTINENCE IN THAI WOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731275 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention