MAUDE MDR 422685

MDR report key
422685
Report number
MW4003380
Event key
0
Event type
3
Date received
2002-09-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RIFE TECHNOLOGY BEAM RAYBEAM RAY*LDQNINININ*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-09-240

Event Narratives#

D

Patient 1

THE COMPLAINANT IS CONCERNED THAT THEIR SIBLING IS PAYING A LOT OF MONEY FOR A QUACK TREATMENT WITH AN UNAPPROVED DEVICE TO CURE THEM OF INFECTION WITH 40 DIFFERENT ORGANISMS. THE COMPLAINANT DIDN'T HAVE ANY DIRECT INFO ABOUT THE PRODUCT OR TREATMENT; JUST THAT PROVIDED BY SIBLING IN A PERSONAL EMAIL. THE PRODUCT IS THE RIFE TECHNOLOGY BEAM RAY (WHICH HAS BEEN AROUND FOR 60+ YEARS). THEY WERE TOLD THE DEVICE IS APPROVED FOR VETERINARY USE BUT NOT HUMAN USE. TO GET AROUND THIS, THE PT HAS TO HOLD A SMALL ANIMAL WHILE RECEIVING TREATMENT. CAREGIVER ALLEGEDLY SELLS THE DEVICE ALSO, BUT BECAUSE IT IS UNAPPROVED, THEY SELL IT IN PIECES INSTEAD OF AS A SINGLE UNIT. THE COMPLAINANT SPOKE TO SOMEONE AT FTC AND WAS TOLD THAT FTC HAS TAKEN ACTION AGAINST A DISTRIBUTOR/PRACTITIONER.