BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE MORCELLEX UNKNOWN PRODUCT

    MDR report key: 5360521 · Received January 12, 2016

    Report

    Report Number
    2210968-2016-00639
    Event Type
    Death
    Date Received
    January 12, 2016
    Date of Event
    October 31, 2014
    Report Date
    December 18, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INFORMATION FOR USE UNDER PRECAUTIONS STATES" CAUTION: THE USE OF A LAPAROSCOPIC TISSUE EXTRACTION BAG IS RECOMMENDED FOR THE MORCELLATION OF MALIGNANT TISSUE OR TISSUE SUSPECTED OF BEING MALIGNANT AND FOR TISSUE THAT THE PHYSICIAN CONSIDERS TO BE POTENTIALLY HARMFUL WHEN DISSEMINATED IN A BODY CAVITY. AS MORCELLATION MAY AFFECT ENDOMETRIAL PATHOLOGIC EXAMINATION, PREOPERATIVE EVALUATION OF THE ENDOMETRIUM SHOULD BE CONSIDERED. SHOULD MALIGNANCY BE IDENTIFIED, USE OF THE GYNECARE MORCELLEX¿ TISSUE MORCELLATOR MAY LEAD TO DISSEMINATION OF MALIGNANT TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A POWER MORCELLATION PROCEDURE ON (B)(6) 2013. THE PATIENT HAD AN UNSUSPECTED LEIOMYOSARCOMA UPSTAGED BY THE MORCELLATOR. IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2014 AS A RESULT OF THE LEIOMYOSARCOMA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20341 GYNECARE MORCELLEX UNKNOWN PRODUCT LAPAROSCOPE, GYNECOLOGIC HET ETHICON INC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R