BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7726749 · Received July 27, 2018

    Report

    Report Number
    2210968-2018-74671
    Event Type
    Injury
    Date Received
    July 27, 2018
    Report Date
    July 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: COULD NOT PROVIDE ADDITIONAL INFORMATION. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? CITATION: WORLD JOURNAL OF UROLOGY; DOI: HTTPS://DOI.ORG/10.1007/S00345-018-2234-6 (B)(4).

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLE : A NEW TREATMENT OF FEMALE STRESS URINARY INCONTINENCE WITH VAGINAL ANTETHECA¿RETROPUBIC SPACE MESH REPAIR SURGERY: A CLINICAL TRIAL. THIS CLINICAL PROSPECTIVE SINGLE ARE STUDY AIMED TO INVESTIGATE THE SHORT- AND MEDIUM-TERM EFFECT OF VAGINAL ANTETHECA SUBMUCOSAL-RETROPUBIC SPACE WITH MESH REPAIR THROUGH THE IMPLANTATION OF ORGANIC PATCH (SHORTLY AS NEW-STYLE VAGINAL MESH REPAIR) IN THE TREATMENT OF PATIENTS WITH STRESS URINARY INCONTINENCE (SUI). FROM JAN2009 TO DEC2014 316 PATIENTS WITH SUI UNDERWENT SURGERY. IN THE PROCEDURE, GYNECARE GYNEMESH PS WAS USED. THE MESH WAS CUT INTO THE SIZE OF 10 CM B 1.2 CM AND PLACED INTO THE POSTERIOR PUBIC SPACE AND FIXED WITH NO.4 THREAD AT THE URETHRAL FASCIA. SEVEN DAYS AFTER SURGERY, 23 PATIENTS SHOWED SYMPTOMS OF URINARY TRACT IRRITATION WHICH ALL RESOLVED AFTER CATHETER REMOVAL AND SYMPTOMATIC TREATMENT. WITHIN ONE MONTH OF SURGERY, 3 PATIENTS HAD MESH EXPOSURE WHICH RECOVERED AFTER ANTI-INFECTIVE TREATMENT AND PRUNING OF THE MESH. WITHIN 3 MONTHS OF THE SURGERY, 17 PATIENTS HAD MESH EXPOSURE WHICH RESOLVED AFTER FURTHER TRIMMING OF THE MESH. THE SURGERY DEMONSTRATED FAVORABLE SHORT-TERM AND MEDIUM-TERM TREATMENT EFFECTS. GIVEN ITS ADVANTAGES OF BEING MINIMALLY INVASIVE, COST EFFICIENT AND REQUIRING ONLY LOCAL ANESTHESIA, THIS NEW SURGICAL TECHNIQUE HAS A POTENTIAL FOR BROADER CLINICAL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570209 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention