BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVI

    MDR report key: 2240782 · Received September 1, 2011

    Report

    Report Number
    MW5022131
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 26, 2011
    Report Date
    September 1, 2011
    Product Code
    JAQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MADE A PREVIOUS REPORT I BELIEVE THIS DEVICE CALLED A SAVI WHICH IS USED FOR 5 DAYS RADIATION WHICH WAS LEFT IN FOR 13 DAYS, HAS CAUSED ME 2 EXTRA OPERATIONS. MINE WAS ONLY STAGE ONE. I HAVE HAD INFECTIONS. MY BREAST NOW LOOKS MORE LIKE A ROAD MAP. I TRULY BELIEVE THIS PRODUCT SHOULD NOT BE USED ON SMALL BREASTED WOMEN. I BELIEVE IT IS LIFE THREATENING BECAUSE OF THIS PRODUCT. I MAY HAVE TO GO IN FOR ANOTHER OPERATION. I CAN NO LONGER HAVE A MAMMOGRAM ON THIS BREAST. IT WILL HAVE TO BE A SONOGRAM; THAT IS HOW MUCH DAMAGE HAS OCCURRED. I AM STILL ON A NARCOTIC TO STOP THE PAIN. PHYSICAL THERAPY, DRAINED A CYST 2 TIMES MAY BE ONE MORE. GOING BACK TO SURGEON (B)(6) 2011. TWO EXTRA NARCOTICS FOR PAIN ON GOING SINCE (B)(6) 2010. OPERATIONS, MRI, SONOGRAM, ANTIBIOTICS, SEVERAL DIFFERENT ONES. MANY DOCTOR APPOINTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVI SAVI JAQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R| S