WESTERN BLOT BLOOD TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for WESTERN BLOT BLOOD TEST manufactured by Unk.

Event Text Entries

[45765601] (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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062391
MDR Report Key5669350
Date Received2016-05-17
Date of Report2016-05-17
Date Added to Maude2016-05-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWESTERN BLOT BLOOD TEST
Generic NameWESTERN BLOT BLOOD TEST
Product CodeLSR
Date Received2016-05-17
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-05-17

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