BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE MORCELLEX UNKNOWN PRODUCT

    MDR report key: 8646632 · Received May 28, 2019

    Report

    Report Number
    2210968-2019-82049
    Event Type
    Death
    Date Received
    May 28, 2019
    Date of Event
    June 13, 2016
    Report Date
    May 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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. IT IS UNKNOWN IF THE ACTUAL DEVICE USED IN THIS PATIENT PROCEDURE WAS IN FACT AN ETHICON MORCELLATOR. THE EVENT INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE IN 2012 AND THE MORCELLATOR WAS USED. IT WAS ALSO REPORTED THAT AFTER PROCEDURE, THE PATIENT DEVELOPED LEIOMYOSARCOMA FROM THE USE OF MORCELLATOR WHICH LEAD TO PATIENT'S DEATH ON (B)(6) 2016. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439548 GYNECARE MORCELLEX UNKNOWN PRODUCT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R