BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8111998 · Received November 28, 2018

    Report

    Report Number
    2210968-2018-77380
    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951984 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention