CURALASE LEVEL IV LASER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-23 for CURALASE LEVEL IV LASER manufactured by Curalase Inc..

Event Text Entries

[65691907] After assurances from (b)(4), a representative and operator of the curalase level iv laser, i signed on for treatments to help stop the degeneration of my cervical discs. I was assured there would be no side effects. He stated that the laser would stimulate my immune system and work to increase my stem cells. He collected 50 percent of the (b)(6) fee and began the series of treatments. The laser went up and down my back, neck, arms and fingers changing positions every 15 seconds. Continued with treatments on (b)(6) when i began having trouble with my hands. I was assured this was normal and would subside. I can supply emails from (b)(4) stating there were no side effects from laser healing and that it was approved by the fda. I continued with treatments on (b)(6) (pain increasing) and (b)(6) 2016 was my last. Both hands now constantly in pain. Especially the left. Sometimes throbbing, sometimes with my fingers getting sensations like shocks when touching anything. I have no grip strength in left hand. Right hand not as bad but fingers still feels pins and needles at times. On top of that there is often a dull intermittent ache in both hands. Sleeping flat on my back very difficult because of unbearable pain. Spent many nights from (b)(6) 2016 to (b)(6) 2016 sitting in a chair for hours at a time. That helped. Tried late night walking, tried aleve and was finally able to sleep. By morning i am unable to close my hands. Making a fist is not possible. The fingers of both hands are aching, swollen and asleep. That is still true today, (b)(6) 2017. I need help to button my shirt in the morning or tie my shoes. My wife has to cut my food. Typing sends electrical like shots up my fingers. Wrapping bows impossible. Trying to handle the pain, i consulted my general practitioner dr. (b)(6) who prescribed acetaminophen with codeine. No help. He then tried tremadol. No help. I decided to stay off pain killers. I am still, ((b)(6) 2017) awakened at least once every night from the pain. Went to see dr. (b)(6), the chiropractor who treated my neck and back issues over the last 4 years, looking for some answers regarding the increasing pain in my hands. Familiar with laser healing she wondered if the laser was damaging the nerve roots and suggested i stop further laser treatments.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067396
MDR Report Key6273663
Date Received2017-01-23
Date of Report2017-01-11
Date of Event2016-10-17
Date Added to Maude2017-01-24
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 NameCURALASE LEVEL IV LASER
Generic NameCURALASE LEVEL IV LASER
Product CodeILY
Date Received2017-01-23
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCURALASE INC.
Manufacturer Address5046 US HWY 17 BYPASS SOUTH #200 MYRTLE BEACH SC 29588 US 29588


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2017-01-23

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