MAUDE MDR 5669350

MDR report key
5669350
Report number
MW5062391
Event key
0
Event type
3
Date received
2016-05-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WESTERN BLOT BLOOD TESTWESTERN BLOT BLOOD TESTUNKLSR* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-1701. S

Event Narratives#

D

Patient 1

(B)(6) TWO-TIER BORRELIA (LYME) TESTING PROTOCOL SAID TWICE I DID NOT HAVE LYME DISEASE. (WESTERN BLOT). I WAITED ALMOST SEVEN YEARS UNTIL CORRECTLY DIAGNOSED. I ALSO HAVE BABESIOSIS. WHY DOESN'T THE (B)(6) HAVE PEOPLE TESTED BY IGENEX WHO ARE CONSISTENTLY PROVEN MORE ACCURATE? I SAW NEUROLOGISTS, EYE SPECIALISTS, ENT SPECIALISTS, GI SPECIALISTS, ORTHODONTIC SPECIALISTS, RHEUMATOLOGISTS, ORTHOPEDIC DOCTORS, BACK SPECIALISTS, PODIATRISTS, HEARING TESTS, PSYCHIATRISTS, CHIROPRACTORS, PHYSICAL THERAPISTS, ACUPUNCTURIST, HAD 2 MRIS, WAS MISDIAGNOSED WITH MYOFASCIAL PAIN SYNDROME, FIBROMYALGIA, THYROID CONDITIONS, CHRONIC FATIGUE IMMUNE DEFICIENCY SYNDROME, MONO, SPENT DAYS IN INPATIENT PHYSICAL THERAPY AND MY FAMILY DECLARED BANKRUPTCY DUE TO ALL THE BILLS. IF GIVEN THE CORRECT TEST SIX AND A HALF YEARS AGO I COULD HAVE BEEN BETTER IN A MONTH. INSTEAD I LOST SEVEN YEARS, HAVE MANY SEVERE HEALTH PROBLEMS FROM THE YEARS OF DAMAGE DONE BY BACTERIA AND A PARASITE. I CAN'T WALK. I HAVE REACTIVE HYPOGLYCEMIA, I AM IN EXTREME PAIN, SWEATS, FEVERS, CHILLS, NAUSEA, DIARRHEA, JUMPING MUSCLES, DEGENERATIVE ARTHRITIS, CONFUSION, MOOD SWINGS, SLEEP 14 HOURS A DAY, AIR HUNGER, AM. ALLERGIC TO EVERYTHING BUT SIX FOODS, RASH ALL OVER, EYES BURN, TONGUE SWELLS, ALLERGIES TO MEDICATIONS I DIDN'T HAVE BEFORE, DYSCALCULIA, DYSLEXIA, ULCERS ON TONGUE, RIB CAGE FEELS STUCK, CONSTIPATION, INSOMNIA FROZEN FEET, SWEATY HEAD. IT DIDN'T HAVE TO BE THIS WAY. CARE MORE.