BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORCELLATION

    MDR report key: 4152622 · Received October 2, 2014

    Report

    Report Number
    MW5038519
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    October 4, 2013
    Report Date
    October 2, 2014
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UNKNOWN CONTINUOUS PELVIC PAIN, NOW AFTER HAVING MORCELLATED MYOMECTOMY SURGERY (B)(6) 2013 OF A RAPIDLY GROWING NECROTIC (NO PRE-NOR PERIOPERATIVE BIOPSY DONE) FIBROID WHILE TAKING IMMUNE MODULATOR MEDICATION X 6 YEARS NOW. PELVIC MIR WITH GAD ((B)(6) 2014), LIGHTING UP AS "METALLIC ARTIFACT" IN SURGICAL AREA, AS PER GATO'S ARTICLE REPORTS; LDH ISOENZYME ELEVATED 59% (MALIGNANT TUMORS POSSIBLE). NO ONE KNOW WHAT TO DO ABOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614138 MORCELLATION MORCELLATION HET

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other