MAUDE Adverse Event Report: CURALASE INC. CURALASE LEVEL IV LASER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Inadequate Pain Relief (2388); Numbness (2415)

Event Date 10/17/2016

Event Type  Injury  

Event Description

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.

• Brand Name: CURALASE LEVEL IV LASER
• Type of Device: CURALASE LEVEL IV LASER
• Manufacturer (Section D): CURALASE INC.; 5046 us hwy 17; bypass south #200; myrtle beach SC 29588
• MDR Report Key: 6273663
• MDR Text Key: 65691907
• Report Number: MW5067396
• Device Sequence Number: 1
• Product Code: ILY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID 90 MCG DAILY; OMEGA; OTC MEDS: VITAMIN D3; RX MEDS: SYNTHROID 150 MCG DAILY
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 72 YR
• Patient Weight: 79