BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC SURGERY

    MDR report key: 3963430 · Received July 24, 2014

    Report

    Report Number
    MW5037450
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    April 18, 2014
    Report Date
    July 24, 2014
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD THE ROBOTIC HYSTERECTOMY SURGERY (B)(6). WENT HOME WITH A CATHETER DUE TO A HOLE IN MY BLADDER, KEPT IT IN FOR 2 WEEKS, STARTING HAVING ISSUES ABOUT A MONTH LATER. PAINFUL URINATION, PAIN IN STOMACH, CRAMPS, DIARRHEA, CAN'T EAT FOOD, NAUSEA, VOMITING, PAIN DOWN MY THIGHS, WEIGHT LOSS, CAN'T HAVE SEX, AND THE LIST GOES ON. I AM CURRENTLY WAITING ON HAVE BLOOD WORK, ULTRASOUND, SEE AN UROLOGIST, A GI DOCTOR ETC. THIS MACHINE SHOULD BE BANNED. I SEE THOUSANDS OF COMPLAINTS JUST LIKE MINE, AND LOOK AT HOW MANY PEOPLE WHO HAVE DIED. THIS SURGERY RUINED MY LIFE AND THE MAKER WILL PAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434877 ROBOTIC SURGERY ROBOT NAY

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| S