LIFE FORCE UNK NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-19 for LIFE FORCE UNK NA manufactured by Life Force.

Event Text Entries

[15191701] The device is patent pending. It was used on pt by her doctor. It is a chamber that is supposed to work on the sympathetic and parasympathetic nervous system, balancing them. "non invasive 21st century alternative healing technology that combines the light, color spectrum and vibrational sound frequency modulation. This creates an environment within a chamber that encourages the human body into a state of total relaxation. " pt has an autonomic neuropathy in her foot. She did not want to go to a pain clinic so she went to an alternative practitioner. They suggested this device. The first time was (b)(6) 2011 and there was no problem. On (b)(6) 2011, she had second treatment and as soon as the machine went on, she began to have pain in her whole spine, knee, foot and base of head. She was in the machine for 55 minutes of her 60 minute treatment. She was shaking in pain. The dr was not there that day and she saw the assistant. Pt was sent to a room to relax and given fluids. She fell to sleep. Four to five hours later, the dr came in and prescribed ultram. She had terrible pain all night long. She took other pain meds and none worked. The next morning, she felt lumps down her spine and on right side of head (frontal lobe), back of head and multiple lumps at base of skull. No one has helped her. She was seen by a chiropractor who did not acknowledge anything she has. Pt has all of the documentation of what she has had done. An echocardiogram (b)(6) 2011 was negative. She returned to the dr and suggested she go into the machine again, changing the color from violet to green (which should be more relaxing). It was not as bad as the second time. Pt was given 2 meds for stress (a drop and a spray). On (b)(6) 2011, she felt dizzy. The next day, she was dizzy and fell. That night she went to the er for pain. All xrays were negative, she was given medications in the hospital and she felt drugged. She lost track of time and was there 2 days. She saw her dr but he didn't have her records. From (b)(6) 2011, she was seeing physicians. Her lymphnodes are enlarged and her thyroid was not functioning properly. The dr saw her and gave her a small amount of medicine for her thyroid. He also agreed she has heart enlargement. On (b)(6) 2011, pt returned to the er and echocardiogram was positive. A ct scan of the head was "fine". Pt is still in pain and she cannot find a dr to help her. Pt believes this is "quackery. " she has bags of supplement she has been given. She now has high blood pressure with it being 25 mg/hg higher in left from right.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5023476
MDR Report Key2382463
Date Received2011-12-19
Date of Report2011-12-19
Date of Event2011-03-14
Date Added to Maude2011-12-22
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIFE FORCE
Generic NameHYPERBARIC CHAMBER
Product CodeCBF
Date Received2011-12-19
Model NumberUNK
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerLIFE FORCE
Manufacturer AddressTAMPA FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-12-19

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