BEUDAMED
    FDA Adverse Event Other Summary report: N

    JACOBSON RESONATOR

    MDR report key: 278764 · Received May 17, 2000

    Report

    Report Number
    MW1018943
    Event Type
    Other
    Date Received
    May 17, 2000
    Date of Event
    March 20, 1999
    Report Date
    May 17, 2000
    Manufacturer
    JACOBSON RESONANCE ENT., INC.
    Product Code
    GZI
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    RPTR'S CHILD WAS TREATED BY A DR (RETIRED DENTIST INACTIVE LICENSE IN THE STATE OF NEW YORK). RPTR FOUND OUT DENTIST HAS NO LICENSE TO PRACTICE IN THEIR STATE. RPTR WAS TOLD THAT THE DEVICE/RESONATOR CREATED RESULTS AND SHOULD REDUCE SPASTICITY AND THIS DEVICE SHOULD HELP CHILD WALK. CHILD HAS CEREBRAL PALSY FROM BIRTH. RPTR WAS TOLD THERE WERE NO SIDE EFFECTS AND THE DEVICE HAD FDA NON SIGNIFICANT RISK (NSR). RPTR LATER LEARNED THAT THE MACHINE/DEVICE HAD FDA NSR ON STUDIES OF OSTEOARTHRITIS OF THE KNEES - 18 INCH MACHINE. NOWHERE ON ANY DOCUMENTS DID IT STATE NSR FOR THE BRAIN OR FOR THE USE OF THE LARGER DEVICE. WHEN RPTR QUESTIONED THIS INFO RPTR WAS DISMISSED FROM THE CLINIC AND DENIED TREATMENT. THREE DAYS LATER CHILD EXPERIENCED SEIZURES FOR FIRST TIME EVER. RPTR WENT TO THE DR AND ASKED DR THIS QUESTION, DR REFUSED TO ANSWER, IGNORED RPTR AND TOLD RPTR THEY WERE A TROUBLEMAKER ETC. THIS DR NOW CLAIMS THAT CLINIC IS UNDER "IRB", ENGAGED IN CLINICAL TRIAL STUDIES FOR NEUROLOGICAL DISORDERS. AT NO POINT IN TIME WAS RPTR INFORMED THAT CHILD WAS IN A CLINICAL TRIAL STUDY. NO CONSENT FORM, "IRB" CLINICAL TRIAL DOCUMENTATION, LENGTH OF STUDY, OPTIONAL TREATMENTS ETC WERE EVER GIVEN TO RPTR OR OTHER PARENTS, OR PTS. RPTR'S QUESTION: HOW CAN A DR TREAT AND CHARGE IN STATE WITHOUT A LICENSE AND SAY TO PTS THAT DR HAS FDA NSR AND NO SIDE EFFECTS. RPTR THINKS THE "KNEE" AND THE BRAIN ARE DIFFERENT PARTS OF THE BODY. "I MAY BE MISTAKEN". ACCORDING TO RPTR THIS MACHINE CAN GENERATE HEAT IN PARTS OF THE BODY, HEADACHES, NOSE BLEEDS ETC. RPTR USED TO SIT IN THE DEVICE HOLDING CHILD OR SIT NEXT TO THE MACHINE. RPTR HAS SUFFERED FROM MAJOR HEADACHES SEVERAL TIMES A WEEK FOR THE LAST YEAR.

    Description of Event or Problem · 2

    RPTR'S CHILD WAS TREATED BY A DR (RETIRED DENTIST INACTIVE LICENSE IN THE STATE OF NEW YORK). RPTR FOUND OUT DENTIST HAS NO LICENSE TO PRACTICE IN THEIR STATE. RPTR WAS TOLD THAT THE DEVICE/RESONATOR CREATED RESULTS AND SHOULD REDUCE SPACITY AND THIS DEVICE SHOULD HELP CHILD WALK. CHILD HAS CEREBRAL PALSY FROM BIRTH. RPT WAS TOLD THERE WERE NO SIDE EFFECTS AND THE DEVICE HAD FDA NON SIGNIFICANT RISK (NSR). RPTR LATER LEARNED THAT THE MACHINE/DEVICE HAS FDA NSR ON STUDIES OF OSTEOARTHRITIS OF THE KNEES - 18 INCH MACHINE. NOWHERE ON ANY DOCUMENTS DID IT STATE NSR FOR THE BRAIN OR FOR THE USE OF THE LARGER DEVICE. WHEN RPTR QUESTIONED THIS INFO RPTR WAS DISMISSED FROM THE CLINIC AND DENIED TREATMENT. THREE DAYS LATER CHILD EXPERIENCED SEIZURES FOR FIRST TIME EVER. RPTR WENT TO THE DR AND ASKED HIM THIS QUESTION, DR REFUSES TO ANSWER INGORED RPTR AND TOLD RPTR THEY WERE A TROUBLE MAKER ETC. THIS DR NOW CLAIMS THAT CLINIC IS UNDER "IRB", ENGAGED IN CLINICAL TRIAL STUDIES FOR NEUROLOGICAL DISORDERS. AT NO POINT IN TIME WAS RPTR INFORMED THAT CHILD WAS IN A CLINICAL TRIAL STUDY. NO CONSENT FORM "IRB" CLINICAL TRIAL DOCUMENTATION, LENGTH OF STUDY, OPTIONAL TREATMENTS ETC WERE EVER GIVEN TO RPTR OR OTHER PARENTS, OR PTS. RPTR'S QUESTION: HOW CAN A DR TREAT AND CHARGE IN STATE WITHOUT A LICENSE AND SAY TO PTS THAT DR HAS FDA NSR AND NO SIDE EFFECTS. RPTR THINKS THE "KNEE" AND THE BRAIN ARE DIFFERENT PARTS OF THE BODY - "I MAY BE MISTAKEN". RPTR BELIEVES WHAT CO PUBLISHES AND WHAT THEY DO IN ACTUAL TREATMENT ARE DIFFERENT. ACCORDING TO RPTR THIS MACHINE CAN GENERATE HEAT IN PARTS OF THE BODY, HEADACHES, NOSE BLEEDS ETC. RPTR USED TO SIT IN THE DEVICE HOLDING CHILD OR SIT NEXT TO THE MACHINE. RPTR HAS SUFFERED FROM MAJOR HEADACHES SEVERAL TIMES A WEEK FOR THE LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACOBSON RESONATOR ELECTROMAGNETIC FIELDS DEVICE GZI JACOBSON RESONANCE ENT., INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other
    2 NO INFO Other