FDA Adverse Event Summary report: N

MERIDIAN STRESS ASSESSMENT MACHINE

MDR report key: 3506657 · Received December 6, 2013

Report

Report Number
MW5033289
Date Received
December 6, 2013
Date of Event
May 1, 2011
Report Date
August 22, 2013
Manufacturer
NA
Product Code
LLZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2008, I HAD A BAD AIRPLANE LANDING WHICH MESSED UP MY NECK. TO PUT THINGS RIGHT, I HAD SOME ADJUSTMENTS DONE BY A CHIROPRACTOR WHO, REVIEWING MY X-RAY, SAW SOME ARTHRITIC CHANGES IN MY UPPER VERTEBRAE. EVEN IF I HAD TWO PREVIOUS ACCIDENTS INVOLVING THE NECK, HE SUGGESTED LOOKING ALSO INTO POSSIBLE NUTRITIONAL DEFICIENCIES WHICH COULD HAVE BEEN CONNECTED TO HAIR THINNING THAT I EXPERIENCED IN MY EARLY TWENTIES. I WAS FEELING SO GOOD THAT I PASSED ON THE SUGGESTION. A COUPLE OF YEARS LATER, I STARTED TO HAVE STIFFNESS IN MY LEFT KNEE UPON AWAKENING IN THE MORNING, SO I LOOKED FOR A DOCTOR WHO INCLUDES NUTRITIONAL MEDICINE IN HIS THERAPEUTIC APPROACH. SO, LITTLE KNEE STIFFNESS AND THINNING HAIR WERE THE TWO REASONS WHY I WENT TO THE DOCTOR. MERIDIAN STRESS ASSESSMENT (MSA) IS AMONG THE TOOLS USED BY THE DOCTOR IN HIS PRACTICE, IT IS A NON INVASIVE, COMPUTERIZED TEST FOR ASSESSING THE OVERALL HEALTH OF ORGANS AND GLANDS BY MEASURING THE ENERGY OF ASSOCIATED ACUPUNCTURE MERIDIANS. DEGREES OF IMBALANCES FOUND IN EACH MERIDIAN ARE ANALYZED AND EVALUATED AGAINST VARIOUS SUBSTANCES TO IDENTIFY POSSIBLE ALLERGIES, INFECTIONS, HEAVY METAL TOXICITY, CHEMICAL TOXICITY, NUTRITIONAL DEFICIENCIES. THIS INSTRUMENT PROVIDES THE PHYSICIAN WITH PATIENT DATA WHICH ASSIST IN DETERMINING THE MAJOR SYSTEMS AND ORGANS OF THE BODY THAT ARE STRESSED OR WEAKENED. THIS INFORMATION, ALONG WITH PATIENT SYMPTOMS, IS COMBINED AND ANALYZED TO DERIVE AT AN OPTIMAL, INDIVIDUALIZED AND EFFECTIVE TREATMENT. MERIDIAN STRESS ASSESSMENT IS NOT MEANT TO REPLACE REGULAR LABORATORY TESTING AND SHOULD BE USED ALONG WITH PHYSICAL EXAMINATION AND MEDICAL HISTORY. LONG STORY SHORT, ALL MY TREATMENTS (SOME OF WHICH I DIDN'T NEED) AND SUPPLEMENTS (THAT THE DOCTOR SELLS IN HIS CLINIC) WERE CHOSEN UPON THE READING OF THIS PIECE OF EQUIPMENT, TOTALLY DISREGARDING LAB WORK, MEDICAL HISTORY AND SYMPTOMS. I DON'T KNOW THE BRAND OF THE DEVICE BECAUSE THE DOCTOR REFUSES TO TELL ME, I JUST KNOW HE IS STILL USING IT, EVEN THOUGH HE IS AWARE OF WHAT HAD HAPPENED TO ME. I AM CONCERNED FOR OTHER PATIENTS, SINCE IN MY CASE THE DEVICE COMPLETELY FAILED. I WAS PUT ON 6 CAPS/DAY [MANUFACTURER SUGGESTED DOSE FOR ADULT IS 1 CAPSULE A DAY OR AS DIRECTED BY PHYSICIAN] OF A GLANDULAR SUPPLEMENT CALLED ENDOGLAND-F WHICH CONTAINS RAW OVARY CONCENTRATE, RAW ADRENAL CONCENTRATE AND RAW PITUITARY CONCENTRATE. IT CAUSED ME TO DEVELOP TUMORS IN THE ADRENAL GLAND, IN THE OVARIES AND IN THE PITUITARY GLAND. MY MEDICAL RECORDS PROVE THAT BEFORE I TOOK THE SUPPLEMENTS, MY GLANDS WERE OK. GLANDULAR IS INDICATED WHEN AN ORGAN IS WEAKENED OR DISEASED OR WHEN A PATIENT'S ENDOCRINE SYSTEM IS UNDER PRODUCING A SPECIFIC HORMONE. I HAD SOME TESTING DONE BEFORE TO SEE THE DOCTOR AND ALL THE HORMONES TESTED [TSH, FT4, T4, TESTOSTERONE, PROLACTIN, CORTISOL, FSH, LH] AND MY OVARIES FUNCTION ANALYSIS WERE OK. ACCORDING TO THE PHARMACIST I TALKED TO AND INFORMATION FOUND IN THE INTERNET, WHEN TAKING GLANDULAR IS RECOMMENDED TO GRADUALLY WORK YOUR WAY UP AND TO BE CAREFULLY MONITORED BY A PHYSICIAN BECAUSE OF FREQUENT ATYPICAL RESPONSES ELICITED WHEN SUCH COMPOUNDS ARE USED. AT HIGH DOSE, THIS SUPPLEMENT MAY TRIGGER A SERIES OF PARADOXICAL AND UNDESIRABLE EFFECTS AS THE BODY'S ABILITY TO HANDLE THE STIMULI REACHES MAXIMUM TOLERANCE LEVEL. AFTER ONE WEEK ON ENDOGLAND-F I WAS EXPERIENCING EXTREME FATIGUE, I COULD BARELY MAKE IT AT WORK AND I WAS ALWAYS SLEEPY, I WAS FUNCTIONING LIKE IN A SLOW MOTION MODE BOTH PHYSICALLY AND MENTALLY, LOW BLOOD PRESSURE, AND HYPOGLYCEMIA. I CALLED THE OFFICE COMPLAINING ABOUT IT AND I WAS TOLD BY THE NATUROPATH (SISTER OF THE DOCTOR) TO DECREASE THE DOSE SLOWLY UNTIL I REACH THE OPTIMAL LEVEL. I TRIED 5, THEN 4, 3, 2 CAPS/DAY AND THEN I STOPPED BECAUSE WITHOUT THE SUPPLEMENT, I WAS MUCH, MUCH BETTER. I TOOK 90 CAPS IN ABOUT TWENTY-TWENTY FIVE DAYS. I STOPPED BEFORE TO GO ON VACATION. WHEN, AFTER THE VACATION, I WENT BACK TO THE DOCTOR, I WAS A LITTLE BIT CONFRONTATIONAL AND UNHAPPY: I HAD NO CLEAR DIAGNOSIS DONE, I HAD RECEIVED SOME TREATMENTS WHICH GAVE ME ZERO BENEFITS, ONE OF THE SUPPLEMENTS MADE ME SICK. HE PUT ME ON IODINE AND, AFTER THREE DAYS, I STARTED TO HAVE THE SYMPTOMS OF WHAT FOUR MONTHS LATER TURNED OUT TO BE CAUSED BY A VERY RARE FORM OF ADRENAL TUMOR CALLED PHEOCHROMOCYTOMA. TUMOR WHICH PRODUCES A GREAT AMOUNT OF CATECHOLAMINES AND GAVE ME MANY SYMPTOMS THAT I NEVER HAD BEFORE: HIGH BLOOD PRESSURE, HYPOGLYCEMIA WITH SHAKING, HEART PALPITATIONS, SWEATING, AGITATION, INSOMNIA, PAIN AND BURNING IN MY BODY ESPECIALLY IN MY HEART, MUSCLE WASTING, HEADACHE (RARELY IN MY LIFE I HAD HEADACHE). THE DOCTOR HAD NOT A CLUE ABOUT WHAT WAS GOING ON WITH ME; HE NEVER SAW ANYTHING LIKE THAT. HE THOUGHT THE SYMPTOMS WERE FROM MERCURY DETOX. EXASPERATED AND SEEKING FOR HELP, I WENT TO THE EMERGENCY ROOM WHERE DIAGNOSIS WAS NOT MADE. IN (B)(6) I ASKED TO A COUSIN RADIOLOGIST TO PLEASE CHECK MY HEART BECAUSE STILL HURTING. HE DID AN ULTRASOUND FROM THE THYROID DOWN TO THE BLADDER AND FOUND TUMORS IN BOTH OVARIES AND IN THE ADRENAL GLAND. BLOOD WORK SHOWED CATECHOLAMINE GROSSLY ELEVATED AND I WAS DIAGNOSED TO HAVE A PHEOCHROMOCYTOMA. I UNDERWENT ADRENALECTOMY AT (B)(6) ON (B)(6) 2011 AND MY SYMPTOMS SUBSIDED. BEFORE THE SURGERY I CONFRONTED THE DOCTOR AND THE SISTER NATUROPATH WHO TOLD ME THAT MOST LIKELY I DEVELOPED TUMORS BECAUSE I WORK ON NIGHT SHIFT AND THEY DON'T DIAGNOSE CANCER IN THEIR OFFICE. WHILE RECOVERING FROM SURGERY, I KEPT THINKING ABOUT ENDOGLAND-F AND I ASKED TO THE ENDOCRINOLOGIST TO HAVE THE PROLACTIN LEVEL CHECKED: 60 NG/ML (NORMAL RANGES 3.34-26.76 NG/ML). SHE ORDERED A MRI WHICH REVEALED A PITUITARY ADENOMA. BEFORE THE SUPPLEMENT MY PROLACTIN LEVEL WAS 8.81 NG/ML - NO TUMOR. ABOUT THE PHEOCHROMOCYTOMA, I DID THE GENETIC TESTING AND I TESTED NEGATIVE FOR ALL THE GENE MUTATIONS THAT PREDISPOSE TO THIS KIND OF TUMOR. I NEVER EXPERIENCED THE SYMPTOMS IN MY LIFE UNTIL (B)(6) 2011. REGARDING THE OVARIES, THEY WERE WORKING FINE (LAB REPORT PROVES IT) AND NO I HAVE ANOVULATORY CYCLE BECAUSE OF THE CYSTS (LAB REPORT PROVE IT). ALL MY MEDICAL RECORDS WILL BE AVAILABLE UPON REQUEST IF INVESTIGATION WILL BE MADE. I DEVELOPED TUMORS AFTER TAKING A GLANDULAR SUPPLEMENT. SUPPLEMENTS AND TREATMENTS WERE GIVEN UPON RESULTS OF A DEVICE CALLED MERIDIAN STRESS ASSESSMENT MACHINE (DON'T KNOW BRAND). DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2011. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2011. DEVICE USED BY DR (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
633444 MERIDIAN STRESS ASSESSMENT MACHINE MERIDIAN STRESS ASSESSMENT MACHINE LLZ NA

Patients

Seq Age Sex Outcome Treatment
1 42 YR Hospitalization| O ENDOGLAND-F. QUANTY: 2 CAPS.| NAME OF THE COMPANY THAT MAKES THE PRODUCT:| FREQUENCY: 3 TIMES A DAY. HOW WAS IT TAKEN: MOUTH.| (B)(4)