BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8111406 · Received November 28, 2018

    Report

    Report Number
    2210968-2018-77377
    Event Type
    Injury
    Date Received
    November 28, 2018
    Report Date
    November 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 112 (2009) 506¿510; DOI:10.1016/J.YGYNO.2008.10.029. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "ABDOMINAL RADICAL TRACHELECTOMY: SUCCESS AND PITFALLS IN A GENERAL GYNECOLOGIC ONCOLOGY PRACTICE," AUTHOR(S): ALEXANDER OLAWAIYE, MARCELA DEL CARMEN, ROSEMARY TAMBOURET, ANNEKATHRYN GOODMAN, ARLAN FULLER, LINDA R. DUSKA, CITATION: GYNECOLOGIC ONCOLOGY 112 (2009) 506¿510; DOI:10.1016/J.YGYNO.2008.10.029. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO REPORT THE SUCCESSES AND COMPLICATIONS WITH A SERIES OF ABDOMINAL RADICAL TRACHELECTOMIES PERFORMED TO PRESERVE FERTILITY IN YOUNG WOMEN AT THE MASSACHUSETTS GENERAL HOSPITAL (MGH). FROM 1999 TO 2007, 10 FEMALE PATIENTS (AVERAGE AGE OF 31.7 YEARS [RANGED 24.8 TO 38 YEARS]) UNDERWENT RADICAL ABDOMINAL "TRACELECTOMY" WITH PELVIC "LYPHADENECTOMY". IN THE PROCEDURE, THE RE-ANASTOMOSIS OF THE FUNDUS TO THE VAGINA WAS PERFORMED USING INTERRUPTED 2-0 PDS SUTURES. THE CERCLAGE WAS ACCOMPLISHED USING MERSILENE BAND WHICH WAS TIED AROUND THE NEO-CERVIX AND THE BLADDER PERITONEUM AND WAS SUTURED OVER THE CERCLAGE. THE STITCH WAS TIED AROUND THE CERVIX WITH KNOT PLACED ANTERIORLY. POSTOPERATIVELY, COMPLICATIONS INCLUDED CERVICAL STENOSIS (N=2) AND DYSPAREUNIA (N=?). THE TWO PATIENTS WITH CERVICAL STENOSIS BOTH CONTINUED TO HAVE REGULAR MENSES WITHOUT HEMATOMETRA (NORMAL ULTRASOUND) BUT A CYTOBRUSH COULD NOT BE INSERTED INTO THE NEW CERVICAL CANAL. LONG TERM COMPLICATIONS INCLUDED 2 CASES OF CERCLAGE EXPULSION IN A (B)(6) AND (B)(6) FEMALE PATIENTS. THE LATTER PATIENT NEEDED OPERATING ROOM VISITS FOR EXAMINATION UNDER ANESTHESIA AND PAP SMEAR. RADICAL ABDOMINAL TRACHELECTOMY CAN BE SUCCESSFULLY PERFORMED BY ANY GYNECOLOGIC ONCOLOGIST WHO IS TRAINED IN RADICAL PELVIC SURGERY. PATIENTS MUST BE AWARE OF POTENTIAL POST-OPERATIVE COMPLICATIONS, INCLUDING PRE-TERM DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950800 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention