BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8181276 · Received December 19, 2018

    Report

    Report Number
    2210968-2018-77907
    Event Type
    Injury
    Date Received
    December 19, 2018
    Report Date
    December 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 USED IN THIS PROCEDURE? CITATION: J. OBSTET. GYNAECOL. 2014; 40(2): 381¿386. DOI: 10.1111/JOG.12207.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EMERGENCY CERCLAGE VERSUS EXPECTANT MANAGEMENT FOR PROLAPSED FETAL MEMBRANES: A RETROSPECTIVE, COMPARATIVE STUDY" AUTHORS: SHIGERU AOKI, EMI OHNUMA, KENTARO KURASAWA, MIKA OKUDA, TSUNEO TAKAHASHI, FUMIKI HIRAHARA. CITATION: J. OBSTET. GYNAECOL. 2014; 40(2): 381¿386. DOI: 10.1111/JOG.12207. THE AIM OF THE STUDY WAS TO COMPARE THE OUTCOMES AFTER EMERGENCY CERCLAGE VERSUS EXPECTANT MANAGEMENT FOR PROLAPSED FETAL MEMBRANES IN WOMEN WITH CERVICAL INCOMPETENCY. THE JANUARY 2000¿DECEMBER 2012 HOSPITAL DATABASE WAS ANALYZED TO IDENTIFY WOMEN MANAGED FOR PROLAPSED FETAL MEMBRANES WHO DID NOT HAVE PREMATURE RUPTURE OF MEMBRANES, CLINICALLY DISCERNIBLE CHORIOAMNIONITIS, OR TREATMENT-RESISTANT UTERINE CONTRACTIONS FROM 15 TO 26 WEEKS OF GESTATION RETROSPECTIVELY. A TOTAL OF 15 OF THE 35 WOMEN (AGE RANGE: 27 TO 42 YEARS OLD) UNDERWENT EMERGENCY CERVICAL CERCLAGE (¿CERCLAGE GROUP¿), WHILE THE OTHER 20 PATIENTS (AGE RANGE: 30 TO 42 YEARS OLD) WERE MANAGED EXPECTANTLY (¿BEDREST GROUP¿). DURING THE SURGICAL PROCEDURE IN THE CERCLAGE GROUP, MERSILENE TAPE (ETHICON) WAS USED. IN THE CERCLAGE GROUP, REPORTED COMPLICATIONS INCLUDED PREMATURE RUPTURE OF MEMBRANE (N-3), DETACHMENT OF MERSILENE TAPE FROM THE CERVICAL MUCOSA (N-2), AND CHORIOAMNIONITIS (N-8). THE PRESENT RESULTS SUGGEST THAT IN WOMEN WITH PROLAPSED FETAL MEMBRANES WHO DO NOT HAVE PROM, TREATMENT-RESISTANT UTERINE CONTRACTIONS OR CLINICAL CHORIOAMNIONITIS, EMERGENCY CERVICAL CERCLAGE ACHIEVES GREATER PROLONGATION OF PREGNANCY THAN EXPECTANT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020469 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention