BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8067035 · Received November 13, 2018

    Report

    Report Number
    2210968-2018-77151
    Event Type
    Injury
    Date Received
    November 13, 2018
    Report Date
    October 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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: AU.TR. NZ J OBSTET GYNECOL. 1998; 38: 1: 27. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "SERIAL "LKANSVAGINAL" ULTRASONOGRAPHY FOLLOWING MCDONALD CERCLAGE AND REPEAT SUTURE INSERTION," AUTHORS: ROBERT FOX, MD, MRCOG, ROBERT HOLMES, MRCOG, MARK JAMES, MRCOG, JEREMY TUOHY, MRCOG AND PETER WARDLE, MD, FRCS, MRCOG. CITATION: AU.TR. NZ J OBSTET GYNECOL. 1998; 38: 1: 27. THE AIM OF THIS STUDY WAS TO EXPLORE THE HYPOTHESIS THAT SERIAL TRANSVAGINAL ULTRASONOGRAPHY IDENTIFIES EARLY EVIDENCE OF SUTURE FAILURE AND THAT REPEAT CERCLAGE DELAYS DELIVERY. THE AUTHORS UNDERTOOK A REVIEW OF OUR POLICY OF TRANSVAGINAL ULTRASONOGRAPHIC CERVICAL SURVEILLANCE AFTER MCDONALD CERCLAGE AND OF REPEAT SUTURE INSERTION IF PERSISTENT CERVICAL EFFACEMENT DEVELOPED. DATA FROM 26 PREGNANCIES IN 26 WOMEN (AGE RANGE: 24 TO 39 YEARS OLD) ARE ANALYZED. DURING THE SURGICAL PROCEDURE, A MCDONALD SUTURE WAS INSERTED UNDER GENERAL OR REGIONAL ANESTHESIA USING MERSILENE 5 MM TAPE (ETHICON) WITHIN 6 HOURS, PROVIDING THAT THERE WAS NO EVIDENCE OF CHORIOAMNIONITIS OR UTERINE CONTRACTIONS. REPORTED COMPLICATIONS INCLUDED ASCENDING INFECTION (N-1), ANTEPARTUM HEMORRHAGE (N-1), AND DEVELOPED CHANGES AFTER THE INSERTION OF THE FIRST SUTURE (N-12) WHICH REQUIRED REPEAT CERCLAGE. THE AUTHORS BELIEVED THAT THE POLICY OF CERVICAL SURVEILLANCE POST-CERCLAGE MAY IMPROVE THE OUTCOME OF PREGNANCY PARTICULARLY FOR THOSE WOMEN WITH A HISTORY HIGHLY SUGGESTIVE OF CERVICAL INCOMPETENCE WHO HAVE HAD PREVIOUS PREGNANCY FAILURES DESPITE CERVICAL CERCLAGE. TO EVALUATE THE ROLE OF ULTRASOUND SURVEILLANCE OF THE CERVIX AFTER MCDONALD CERCLAGE, THE AUTHORS SUGGESTED THAT THIS PROTOCOL SHOULD BE SUBJECTED TO A RANDOM-ALLOCATION, INTERVENTION TRIAL, COMPARING STANDARD OBSTETRIC MANAGEMENT AFTER CERCLAGE WITH A POLICY OF SERIAL ULTRASONOGRAPHY (AND REPEAT SUTURE INSERTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906379 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention