BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 9199416 · Received October 16, 2019

    Report

    Report Number
    2210968-2019-88701
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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: ACTAS UROL ESP. 2007; 31(10): 1141-1147. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE : TRANS-OBTURATOR TAPE (TOT) IN THE CORRECTION OF STRESS URINARY INCONTINENCE. THREE-YEAR EXPERIENCE WITH 200 PATIENTS." AUTHOR : PARDO SCHANZ J1,2, RICCI ARRIOLA P2, TACLA FERNÁNDEZ X1, BETANCOURT ORTIZ E. CITATION: ACTAS UROL ESP. 2007; 31(10): 1141-1147. THE OBJECTIVES OF THE STUDY WAS TO ASSESS THE SAFETY AND EFFICACY OF THE TOT IN THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE, ACCORDING TO THE AUTHORS EXPERIENCE. THIS IS A PROSPECTIVE STUDY OF 200 PATIENTS (AGE RANGE: 34 TO 78 YEARS OLD) WHO UNDERWENT TOT IN THE GYNECOLOGY UNIT OF THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY OF THE BARROS LUCO-TRUDEAU HOSPITAL, BETWEEN JANUARY 2003 AND OCTOBER 2006. A PROLENE MONOFILAMENT MESH (ETHICON) WAS USED DURING THE PROCEDURE. REPORTED COMPLICATIONS INCLUDED URINARY INFECTION (LOWER URINARY TRACT INFECTION; N-1) WHICH REQUIRED ANTIBIOTIC THERAPY, LOWER EXTREMITY PAIN (N-3) WHICH REQUIRED ANALGESIC DRUGS, DISPLACEMENT OF THE TAPE AT THE THIRD MONTH (N-1) WHICH REQUIRED NEW SURGERY, AND FAILURE OF THE SURGERY, MAINTAINING THE STRESS INCONTINENCE (N-10). THE TOT IS A TECHNIQUE WHOSE MODIFICATIONS COMPARED TO TVT, REDUCE THE TIME OF SURGERY AND ITS COMPLICATIONS. TOT IS A SAFE AND EFFECTIVE TECHNIQUE IN THE SURGICAL CORRECTION OF STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989731 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention