BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 1980021 · Received February 1, 2011

    Report

    Report Number
    MW5019235
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    August 17, 2010
    Report Date
    February 1, 2011
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TEN DAYS POST UAE, BEGAN TO EXPERIENCE EXTREME PELVIC PAIN. WENT TO THE ER WHERE EXTREME PAIN WAS ACCOMPANIED BY VOMITING. CT SCAN SHOWED AN OVARIAN CYST AND WAS SENT HOME WITH PERCOCET FOR PAIN CONTROL. THE PERFORMING IR SAID THINGS WERE GOING WELL AND RECOVERY WOULD TAKE A BIT LONGER THAN AVERAGE. AT 32 DAYS POST UAE, STILL EXPERIENCING SEVERE PAIN ON AND OFF. ADD'L PAIN MEDS REQUIRED AT NIGHT. BARELY ABLE TO FUNCTION, ONLY DOING MINIMAL NECESSARY HOUSEHOLD CHORES. GYNECOLOGIST PERFORMED SONOGRAM AND DID NOT SEE ANYTHING WRONG. GYN SAID SHE WOULD HAVE TO "SUFFER THROUGH" AND TO LET HER KNOW WHEN SHE HAD ENOUGH, AND SHE WOULD PERFORM A HYSTERECTOMY. PRIOR TO UAE, WAS A VERY ACTIVE WOMAN WHO WORKED OUT, HAD A HEALTHY DIET, AND WAS NOT OVERWEIGHT. WEIGHT PRIOR (B)(6); 30 DAYS POST UAE, WEIGHT IS (B)(6). SHE WOULD NEVER RECOMMEND THIS PROCEDURE AND IS SORRY SHE HAD IT DONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R