BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8026179 · Received October 31, 2018

    Report

    Report Number
    2210968-2018-76869
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: AUST NZ J OBSTET GYNAECOL. 1999; 39: 2-155.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EMERGENCY CERVICAL CERCLAGE. IS THERE A ROLE FOR AMNIOREDUCTION?" AUTHORS: ANTHONY J. CERQUI, MRACOG; EMILY OLIVE, MRACOG; MICHAEL J. BENNETT, MD, FRCOG, FRACOG, DDU; DANIEL CHALLIS, FRACOG, DDU, CMFM. CITATION: AUST NZ J OBSTET GYNAECOL. 1999; 39: 2-155. THE AUTHORS PRESENTED 3 CASES OF EMERGENCY CERVICAL CERCLAGE ASSISTED BY AMNIOREDUCTION WHICH WE BELIEVE MAY BE USEFUL TOOL IN THE STUDY. CASE 3, A (B)(6)-YEAR-OLD WOMAN IN HER SECOND PREGNANCY PRESENTED AT 18 WEEKS GESTATION IN JUNE 1998 WITH PINK SPOTTING FOR THE PRECEEDING 3 DAYS AND A SUDDEN ONSET OF ABDOMINAL CRAMPS. ON VAGINAL EXAMINATION, BULGING FOREWATERS WERE FOUND PROTRUDING THROUGH THE CERVIX. AMNIOREDUCTION AND EMERGENCY CERCLAGE WAS PERFORMED. DURING THE PROCEDURE, 200 ML OF LIQUOR WAS DRAINED AND A MCDONALD SUTURE USING MERSILENE TAPE (ETHICON) WAS INSERTED. SEVENTY HOURS LATER, THE PATIENT HAD SPONTANEOUS MEMBRANE RUPTURE AND ACUTE CHORIOAMNIONITIS WHICH REQUIRED SUTURE REMOVAL. THERE ARE REPORTS OF AN INCREASED INCIDENCE OF POST-OPERATIVE CHORIOAMNIONITIS USING POLYFILAMENT MERSILENE COMPARED TO A MONOFILAMENT SUTURE. THE SUTURE TECHNIQUE USED IS HOWEVER PROBABLY OF LITTLE IMPORTANCE IN DETERMINING PREGNANCY OUTCOME. IF INFECTION SUPERVENES, THE STITCH NEEDS TO BE REMOVED AND DELIVERY EXPEDITED. A NUMBER OF MEASURES EXIST TO REDUCE PROLAPSED MEMBRANES AND THE DECISION TO CHOOSE ONE SHOULD BE BASED ON CLINICAL EXPERIENCE AND THE FEATURES PARTICULAR TO AN INDIVIDUAL PATIENT. AMNIOREDUCTION APPEARS TO FACILITATE REDUCTION OF THE MEMBRANES AND ASSIST IN THE DIAGNOSIS OF SUBCLINICAL CHORIOAMNIONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865881 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention