BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOLIZATION DEVICE

    MDR report key: 3806921 · Received May 7, 2014

    Report

    Report Number
    MW5036036
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Product Code
    NAJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WITH PRESUMED FIBROID TUMORS TREATED WITH UTERINE ARTERY EMBOLIZATION. THERE WAS NO DIAGNOSTIC EXCLUSION OF SARCOMA BEFORE TREATMENT, THEREFORE THIS PT COULD HAVE LIFE THREATENING UNTREATED SARCOMA. THIS IS EVEN WORSE THAN MORCELLATION OF A SARCOMA, LEAVING A SARCOMA IN THE BODY TO GROW W/O TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276276 EMBOLIZATION DEVICE UTERINE ARTERY EMBOLIZATION NAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening