BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINA XCISE

    MDR report key: 5384733 · Received January 22, 2016

    Report

    Report Number
    3007699067-2016-00001
    Event Type
    Death
    Date Received
    January 22, 2016
    Date of Event
    March 6, 2012
    Report Date
    January 15, 2015
    Manufacturer
    LINA MEDICAL APS
    Product Code
    HET
    PMA / PMN Number
    K101458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A HYSTERECTOMY WITH POWER MORCELLATOR TO TREAT UTERINE BLEEDING ON (B)(6) 2012. NO REPORTS OF ADVERSE EVENTS INVOLVING THIS PATIENT WERE REPORTED TO THE HOSPITAL. THE HOSPITAL WAS INFORMED THAT A WRIT OF SUMMONS WAS FILED ON 3/14/14. THIS WRIT IDENTIFIED THE PATIENT'S NAME BUT CONTAINED NO SUBSTANTIVE INFORMATION. IT IS OUR UNDERSTANDING THAT AFTER THE PROCEDURE, THE PATIENT DEVELOPED LEIOMYOSARCOMA AND DIED ON (B)(6) 2013. AT THE TIME OF THIS EVENT THERE WAS NO EVIDENCE OF FAILURE OF THE MEDICAL DEVICE OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO PATIENTS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45634 LINA XCISE LINA XCISE HET LINA MEDICAL APS LINA XCISE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death