BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8090712 · Received November 20, 2018

    Report

    Report Number
    2210968-2018-77254
    Event Type
    Injury
    Date Received
    November 20, 2018
    Report Date
    November 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: GYNECOL SURG. 2012; 9: 219¿222. DOI: 10.1007/S10397-011-0691-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "ABDOMINAL CERCLAGE AFTER FAILED TRANSVAGINAL CERVICAL CERCLAGE." AUTHORS: ANWAR MORIA & NOUF ALJAJI & LOUISE MINER & TOGAS TULANDI. CITATION: GYNECOL SURG. 2012; 9: 219¿222. DOI: 10.1007/S10397-011-0691-7. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF ABDOMINAL CERCLAGE BY LAPAROTOMY AND BY LAPAROSCOPY AMONG WOMEN WHO HAD FAILED TRANSVAGINAL CERCLAGE. THE AUTHORS EVALUATED ALL WOMEN WITH CERVICAL INSUFFICIENCY THAT UNDERWENT ABDOMINAL CERCLAGE BETWEEN THE YEARS 2000 AND 2010. OF A TOTAL OF 20 PATIENTS, 12 PATIENTS (AGE: 34.4 ± 1.3; BMI: 24.9 ± 1.6) UNDERWENT ABDOMINAL CERCLAGE BY LAPAROSCOPY AND 8 PATIENTS (AGE: 34.2 ± 0.8; BMI: 23.3 ± 2.4) UNDERWENT ABDOMINAL CERCLAGE BY LAPAROTOMY. DURING THE PROCEDURE IN BOTH TECHNIQUES, THE AUTHORS STARTED BY DISSECTING THE BLADDER PERITONEUM OFF THE CERVIX AND THE AUTHORS USED MERSILENE 5-MM TAPE (ETHICON) FOR THE CERCLAGE. IN THE LAPAROTOMY TECHNIQUE, THE SUTURE WAS INSERTED THROUGH THE AVASCULAR AREA OF THE PARACERVICAL TISSUE MEDIAL TO THE UTERINE VESSELS AND AT THE LEVEL OF THE UTERINE ISTHMUS. IN THE LAPAROSCOPIC GROUP, REPORTED COMPLICATIONS INCLUDED SEVERE OLIGOHYDRAMNIOS (N-1) WHICH REQUIRED LAPAROSCOPIC REMOVAL OF THE CERCLAGE. IN THE LAPAROTOMY GROUP, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-1) AND URINARY TRACT INFECTION (N-1). THE AUTHORS CONCLUDED THAT ABDOMINAL CERCLAGE IN WOMEN WHO HAVE FAILED A TRANSVAGINAL CERVICAL CERCLAGE IS ASSOCIATED WITH A HIGH LIVE BIRTH RATE AND IT COULD BE PERFORMED BY LAPAROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930785 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention