BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 7941193 · Received October 5, 2018

    Report

    Report Number
    2210968-2018-76367
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION AVAILABLE. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PLEASE PROVIDE THE SPECIFIC PRODUCT CODE AND LOT NUMBER INVOLVED. CITATION: HINDAWI PUBLISHING CORPORATION BIOMED RESEARCH INTERNATIONAL. 2014; 296498: 7. DOI: HTTP://DX.DOI.ORG/10.1155/2014/296498. (B)(4).

    Description of Event or Problem · 1

    TITLE: COATING OF MESH GRAFTS FOR PROLAPSE AND URINARY INCONTINENCE REPAIR WITH AUTOLOGOUS PLASMA: EXPLORATION STAGE OF A SURGICAL INNOVATION. OPTIMIZED BIOCOMPATIBILITY IS A MAJOR REQUIREMENT FOR ALLOPLASTIC MATERIALS CURRENTLY APPLIED FOR STRESS URINARY INCONTINENCE (SUI) AND PELVIC ORGAN PROLAPSE (POP) REPAIR. IN THE PRELIMINARY STUDIES, THE MESH MODIFICATION BY COATING WITH AUTOLOGOUS PLASMA RESULTED IN THE INCREASED ADHERENCE SCORE IN VITRO AND IMPROVED BIOCOMPATIBILITY IN AN ANIMAL MODEL. THE FIRST USE OF PLASMA COATED MESHES IN HUMAN IS PRESENTED. BETWEEN 04/2013 AND 05/2014, A TOTAL OF 20 PATIENTS (16 FEMALE AND 4 MALE PATIENTS; AGE RANGE: 45 TO 85 YEARS OLD) WITH THE INDICATION FOR SUI AND POP REPAIR WERE SELECTED IN A SINGLE INSTITUTION. DIFFERENT MESH MATERIALS WERE USED DURING THE PROCEDURE. IN THE TVT GROUP, TVT MESH (ETHICON; N-7) WAS USED AND IN THE ANTERIOR VAGINAL MESH GROUP, ULTRAPRO MESH (ETHICON; N-1) WAS USED. IN THE TVT GROUP, REPORTED COMPLICATIONS INCLUDED GRADE I HEMATOMA (N-1), GRADE I URGE DE NOVO (N-3), GRADE I OBSTRUCTION (N-1), GRADE II URINARY TRACT INFECTION (N-2), GRADE III OBSTRUCTION (N-2) WHICH REQUIRED CYSTOSCOPIC RELEASE OF TVT-MESH IN ANESTHESIA, AN (B)(6) FEMALE PATIENT WITH PROLONGED VOIDING DYSFUNCTION AFTER TVT WHICH REQUIRED INSERTION OF SUPRAPUBIC TUBE AND THE MEDICATION WITH UBRETID WAS STARTED, AND A (B)(6) FEMALE PATIENT WITH PERSISTENT STRESS URINARY INCONTINENCE AND CYSTOCELE WHICH REQUIRED RE-OPERATION WITH COLPORRHAPHY AND PLASMA-COATED VAGINAL MESH APPLICATION. IN THE ANTERIOR VAGINAL MESH GROUP, REPORTED COMPLICATION INCLUDED GRADE I OBSTRUCTION (N-1). IT WAS REPORTED THAT FOR THE FIRST TIME, THE AUTHORS APPLIED A MESH MODIFICATION IN A HUMAN SETTING ACCORDING TO IDEAL CRITERIA OF SURGICAL INNOVATIONS. THE PROCEDURE OF MESH COATING WITH AUTOLOGOUS PLASMA IS SAFE AND A PROSPECTIVE RANDOMIZED TRIAL PROVING A POSITIVE EFFECT OF PLASMA COATING ON THE BIOCOMPATIBILITY AND MORBIDITY OUTCOME WITH LONG-TERM REGISTRY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781917 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention