SOFT COLD LASER, LOW LEVEL, HELIUM NEON THERAPY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-27 for SOFT COLD LASER, LOW LEVEL, HELIUM NEON THERAPY * manufactured by *.

Event Text Entries

[16643246] Pt has prostate cancer which has left him paralyzed and with speech problems from 3 tumors on his spinal cord. Someone identified himself as a chiropractor attempted to sell complainant soft cold 8 laser low level large 632 helium neon therapy unit for $45,000 to treat condition. They visited house with equipment on trailer demanding payment for the device. Complainant did not have immediate funds available, but gave something. Board of chiropractic licensure stated that they had not renewed license since 01 (revoked) and is not licensed. Claims device cures cancer by increasing blood flow and causes nerve cells to vibrate, which stimulates t-cell growth. Puts pts on vitamin regimen to help process. Given no written instructions, little training, and no supervision for 5 days worth of use. Dr recommended at least 10 treatments per day, 5-10 seconds per area treated, front and back of whole body. Could not overdo treatments.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003967
• MDR Report Key: 756929
• Date Received: 2005-07-27
• Date of Report: 2005-05-16
• Date of Event: 2005-05-08
• Date Added to Maude: 2006-09-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SOFT COLD LASER, LOW LEVEL, HELIUM NEON THERAPY
• Generic Name: *
• Product Code: HCC
• Date Received: 2005-07-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 744825
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-07-27