BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTON THERAPY

    MDR report key: 4377748 · Received December 26, 2014

    Report

    Report Number
    MW5039862
    Event Type
    Injury
    Date Received
    December 26, 2014
    Date of Event
    May 10, 2007
    Report Date
    December 26, 2014
    Manufacturer
    OPTIVUS PROTON THERAPY
    Product Code
    LHN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2006, I WAS DIAGNOSED WITH PROSTATE CANCER. IN (B)(6) 2007, I UNDERWENT PROTON RADIATION THERAPY AT (B)(6). IN (B)(6) 2010, I WAS DIAGNOSED WITH RADIATION CYSTITIS TO THE BLADDER. IN (B)(6) 2010, I UNDERWENT A COMPLETE BLADDER REPLACEMENT BECAUSE OF THE CYSTITIS AND THE RADIATION INDUCED MALIGNANCY I SUSTAINED DURING PROTON THERAPY. AT FIRST I WAS VERY PLEASED WITH TREATMENTS AT (B)(6), I PRESUMED EVERYTHING WAS VERY EFFICIENT. I DID NOTICE AT THE TIME, BUT NOW LOOKING BACK IT REMINDS ME OF AN ASSEMBLY LINE WITH PTS STACKED UP ONE AFTER THE OTHER. NO TIME TO BE CAREFUL OR TO MAKE SURE ALL PROPER SAFETY ELEMENTS ARE IN PLACE, GET IN THE TREATMENT POD RECEIVE YOUR DOSE AND GET OUT. ON OCCASIONS, IF YOU CAN'T HOLD YOUR PROTECTIVE WATER, THE TECHNICIANS WOULD ASSIST YOU IN EMPTYING YOUR BLADDER, WHILE IN THE POD, AND THEN BEAM YOU WITH RADIATION TOTALLY UNPROTECTED. I HAVE REQUESTED FROM (B)(6) THEIR TREATMENT PROTOCOL, THEY DO NOT HAVE A TREATMENT PROTOCOL.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 05/15/2015. WE WRITE IN RESPONSE TO YOUR LETTER OF (B)(6), 2015 AND THE ATTACHED REPORT MW5039862. WE WOULD LIKE TO CLARIFY THAT OPTIVUS PROTON THERAPY, INC. IS NOT THE MFR OF THE MEDICAL DEVICE REFERRED TO . OPTIVUS DID NOT DESIGN OR MANUFACTURE THE DEVICE. IN FACT, OPTIVUS DID NOT COME INTO EXISTENCE UNTIL 1993, THREE YEARS AFTER CONSTRUCTION OF THE PROTON BEAM THERAPY SYSTEM AT (B)(6) MEDICAL CENTER WAS COMPLETED AND PTS BEGAN RECEIVING TREATMENT. FURTHERMORE, OPTIVUS KNOWS THE INITIAL REPORTER, (B)(6). HE IS THE PLAINTIFF IN A PERSONAL INJURY CASE AGAINST OPTIVUS, (B)(6) MEDICAL CENTER ((B)(6)) AND ANOTHER DEFENDANT. IN 2007, WHEN MR. (B)(6) UNDERWENT PROTON THERAPY AT (B)(6), OPTIVUS PROTON THERAPY, INC. HAD A CONTRACT WITH (B)(6) TO PROVIDE MAINTENANCE AND TECHNICAL UPGRADES ON THE MEDICAL DEVICES IN (B)(6) PROTON THERAPY CENTER, BUT DID NOT INTERACT WITH PTS DURING THEIR TREATMENTS. OPTIVUS HAS TOLD MR. (B)(6) REPEATEDLY THAT DID NOT MANUFACTURE THE DEVICE AND WAS NOT FORMED AS A COMPANY UNTIL THREE YEARS AFTER THE PROTON THERAPY DEVICE WAS UP AND RUNNING. OPTIVUS IS CONCERNED THAT MR. (B)(6) HAS PROVIDED FDA WITH INACCURATE INFO, AS REFLECTED IN ITS MAUDE EVENT REPORT ENCLOSED WITH YOUR LETTER, IN ORDER TO GAIN AN IMPROPER ADVANTAGE IN HIS LAWSUIT. AGAIN WE EMPHASIZE THAT OPTIVUS IS NOT THE MFR. BASED ON THE FOREGOING, OPTIVUS HAS DETERMINED THAT IT IS NOT APPROPRIATE FOR IT TO FILE A MEDICAL DEVICE REPORT (MDR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852617 PROTON THERAPY PROTON THERAPY LHN OPTIVUS PROTON THERAPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention