MICRO ACUPUNCTURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-27 for MICRO ACUPUNCTURE manufactured by Na.

Event Text Entries

[179202] Pt suffers from hypothyroidism as a result of radioactive iodine in 1988 for graves disease and hyperactive thyroid. Synthroid stabilized condition without any side effects. In 1993, pt changed drs to a dr who switched to westroid because dr felt pt might do a little bit better with a natural product. Pt had difficulty adjusting to the dosage of 2 grains. Dr did not test pt or acquire pt's medical records prior to this decision. Pt was suffering with edema and weight gain at that time. Dr recommended acupuncture, and because pt was married to an acupuncturist, pt chose to receive treatment from them. Pt was treated with micro acupuncture in 1993. They said it was to improve pt's vision, but also told pt that it would help with everything. In 3 mos, and while pt was on westroid, pt noticed a change that wasn't normal. Pt began having swelling in throat that would cease when pt didn't take westroid. Pt found that they had to get off their medicine to get relief. It was a choking sensation that was like strangulation. Pt was off of medicine by 1994. Pt was refused medical attention for this complication because it would raise questions with fda since fda told the acupuncturist that they could practice these treatments after they told them the treatments were only for macular degeneration pts when the truth was and is they treat all eye diseases with the same treatments. In 1994 pt returned to dr to find out that their thyroid tsh, t3, and t4 levels were out of range. Tsh rose to 109. Pt was suffering severe head pain and stomach pain. Pt's head hurt for years. It took 2 1/2 yrs for tsh to return to normal. It took 3 or 4 mos for dr to get pt back on synthroid. Pt has been on synthroid or levoxyl since then and levels are checked yearly. Pt's dr who put them on westroid told pt that now that tsh has reached over 100, pt has a risk of getting arteriosclerosis. No one has checked this out and pt's drs treating them now don't want to get those records. After being told thyroid was dead and this was not possible, pt took a thyroid scan to determine if this was true. Scan showed a thyroid. Just before pt had the scan done, pt was hit with some kind of "sonic weapon containing some kind of gas or nuclear energy that penetrated pt's body through their back in a circular motion. " it left pt defenseless. Pt endures consequences that led them to believe it contained nuclear material. "it moved into pt's bloodstream and pt could feel it running through their blood and in their head. Pt drank galloons of water and it came out in large shapes of oil beads in their urine. Pt's head hurt severely and pt created interference with television sets and radios from a distance of about 10 feet. Pt felt constant vibrations in their abdomen during this time. Today, pt can bring in reception to radios with antennas. " exactly three years later in 1997, pt had something "growing in my throat. It was flopping around and hung about 1 1/2 inches. It had been growing for a long time. " pt went to the emergency room on several occasions telling them their head hurt. Pt had severe infections from 1994 to recently and is always treated with high doses of antibiotics. "the item in my throat choked me and fell out. It was about 1 1/2 inches long, bluish green in color, shaped like a worm, about 1/4" in diameter, and was glowing. I became frightened and ran away. I had other discharge that was very abnormal and several odd shaped objects that resembled solid flat webbed shapes that came out clean in my stools and strong odor discolored discharge from my urethra that was not urine. " pt sought a psychiatrist in 1995 until pt was called a liar in 2000. Pt has been on moban and other psychotic medication but breaks out in welts until they bleed. Pt has been on tranquilizers and antidepressants off and on over the years and is currently off of the medication. Pt was on medication when "psychiatrist called me a liar. " pt has since developed meniere's disease and has periodic vertigo spells. Pt is on triamterene which seems to have been the answer. However, the disease has not been proven through testing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1019199
MDR Report Key283867
Date Received2000-06-27
Date of Report2000-06-20
Date of Event1993-06-01
Date Added to Maude2000-07-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMICRO ACUPUNCTURE
Generic NameACUPUNCTURE NEEDLE INJECTED IN THE BONE OF HANDS & FEET
Product CodeMQX
Date Received2000-06-27
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key274699
ManufacturerNA
Manufacturer AddressNA NA *


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2000-06-27

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