BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8066979 · Received November 13, 2018

    Report

    Report Number
    2210968-2018-77150
    Event Type
    Injury
    Date Received
    November 13, 2018
    Report Date
    October 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: GYNECOLOGIC ONCOLOGY. 2011; 121: 565-570. DOI: 10.1016/J.YGYNO.2011.01.032. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RADICAL ABDOMINAL TRACHELECTOMY FOR CERVICAL MALIGNANCIES: SURGICAL, ONCOLOGICAL AND FERTILITY OUTCOMES ON 62 PATIENTS" AUTHORS: JIN LI, ZITING LI, HUAYING WANG, RONGYU ZANG, YUQI ZHOU, XINGZHU JU, GUIHAO KE, XIAOHUA WU. CITATION: GYNECOLOGIC ONCOLOGY. 2011; 121: 565-570. DOI: 10.1016/J.YGYNO.2011.01.032. THE OBJECTIVES OF THE STUDY WAS TO REPORT THE AUTHORS¿ EXPERIENCE OF RADICAL ABDOMINAL TRACHELECTOMY FOR PATIENTS WITH CERVICAL MALIGNANCIES. THE AUTHORS CONDUCTED A RETROSPECTIVE REVIEW OF A PROSPECTIVELY MAINTAINED DATABASE OF 64 PATIENTS (AGE RANGE: 11 TO 41 YEARS OLD) WHO UNDERWENT FERTILITY-SPARING RADICAL ABDOMINAL TRACHELECTOMY FOR CERVICAL MALIGNANCIES. DURING THE SURGICAL PROCEDURE, ONCE THE SPECIMEN IS REMOVED, A MERSILENE TAPE (ETHICON) IS CIRCUMFERENTIALLY PLACED IN THE SUBSEROSA AROUND THE LOWER UTERINE SEGMENT IN A PURSE-STRING TECHNIQUE AS A PERMANENT CERCLAGE. THE TAPE KNOT IS TIED POSTERIORLY IN THE CUL DE SAC. REPORTED COMPLICATION INCLUDED POST-OPERATIVE CERVICAL STENOSIS (N-5) WHICH REQUIRED NEO-CERVICAL DILATION IN 1 PATIENT, VESICAL DYSFUNCTION (N-1) WHICH REQUIRED RE-INSERTION OF FOLEY CATHETER, DYSPAREUNIA (N-7), PAIN DURING INTERCOURSE (N-6), AND BLEEDING OR SPOTTING AFTER INTERCOURSE (N-7). THE RESULTS SHOWED THAT RADICAL ABDOMINAL TRACHELECTOMY IS FEASIBLE AND CAN BE PERFORMED SAFELY IN WELL-SELECTED PATIENTS WITH CERVICAL MALIGNANCIES WHO WISH TO PRESERVE THEIR FERTILITY. SOCIAL, FAMILIAL, AND PHYSICAL FACTORS CAN LARGELY INFLUENCE THE PATIENTS¿ REPRODUCTIVE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904381 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention