BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTERINE FIBROID MORCELLATOR

    MDR report key: 8527924 · Received April 17, 2019

    Report

    Report Number
    MW5085980
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    February 1, 2019
    Report Date
    April 17, 2019
    Manufacturer
    UNK
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT IN 2007, SHE HAD A FIBROID REMOVED WITH A UTERINE FIBROID MORCELLATOR. PT STATED AT THAT TIME NO CANCER WAS FOUND. PT SAID IN (B)(6) OF 2019, SHE HAD ENLARGED LYMPH NODES, HER PHYSICIAN SENT HER FOR AN ULTRASOUND ON (B)(6) 2019, WHICH SHOWED HER SPLEEN WAS ENLARGED. PT SAID SHE HAS NOW BEEN REFERED TO AN ONCOLOGIST. PT IS CONCERNED AND WORRIED THAT THIS COULD BE FROM THE MORCELLATOR USED BACK IN 2007 FOR HER FIBROID REMOVAL. PT SAID SHE IS CONCERNED THIS DEVICE IS NOT SAFE AND THIS PROCEDURE COULD BE CAUSING CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314426 UTERINE FIBROID MORCELLATOR LAPAROSCOPIC, GENERAL & PLASTIC SURGERY GCJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other