FDA.reportPublic FDA data

MAUDE MDR 756929

MDR report key
756929
Report number
MW4003967
Event key
0
Event type
3
Date of event
2005-05-08
Date received
2005-07-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOFT COLD LASER, LOW LEVEL, HELIUM NEON THERAPY**HCC***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-07-270

Event Narratives#

D

Patient 1

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.