inforMED
InjuryITH

AXIOM WORLDWIDE

Received Sep 3, 2007 · Event occurred Sep 18, 2006

Report MW5003633 · MDR key 908350

Device

Generic name

Drx-9000

Manufacturer

Axiom Worldwide

Model number

DRX-9000

Product problems

  • Unknown (for use when the device problem is not known)

Patient

47 YR

  • Sprain
  • Identified diagnosis
  • Hospitalization required

Narrative

Description of Event or Problem

I WAS DUPED BY THE ADVERTISEMENTS THAT AXIOM WORLDWIDE RAN IN 2006, STATING THAT THE DRX-9000 WAS "APPROVED BY THE FDA;" WAS "86% SUCCESSFUL IN CLINICAL TRIALS, ETC," AND FURTHER PRESSURED BY A CHIROPRACTOR WHO WAS PROMOTING THEIR DEVICE. IMMEDIATELY AFTER BEING "APPROVED FOR TREATMENT" BY A CHIROPRACTOR, I WAS STRAPPED INTO THE DRX-9000 AND "TREATED." WITHIN 2 HRS OF THIS TREATMENT, I WAS TREATED IN THE HOSP FOR STRAINED LUMBAR SPINE. ON FOLLOW UP, I LEARNED I HAD HERNIATED DISCS IN MY LUMBAR SPINE AND MULTIPLE DISCS IN MY CERVICAL SPINE. THIS DEVICE WAS CERTIFIED ON A PREDICATE DEVICE. -VAX-D-, AND SHOULD HAVE ITS CLEARANCE PULLED DUE TO THE CO'S FALSE ADVERTISING, AND A COMPLETE LACK OF CLINICAL TRIALS. RESEARCH ON THE INTERNET SEEMS TO INDICATE THE TECHNOLOGY FOR THIS DEVICE WAS "TAKEN" FROM SOME OTHER CO. THE MARKETING USED IN PROMOTING THIS DEVICE SEEMED TO CREATE SUCH A HIGH LEVEL OF GREED WITH THE CHIROPRACTORS WHO PURCHASED. IT, THAT MANY PEOPLE WHO DO NOT NEED THIS THERAPY ARE BEING TREATED ANYWAY. IN FACT, I DID NOT HAVE LUMBAR OR CERVICAL PROBLEMS AT ALL UNTIL I WAS PLACED ON THE DRX-9000. NOW I AM FACING MULTIPLE SURGERIES AND POSSIBLE PERMANENT DISABILITY. I PRAY THAT THE INNOCENT PEOPLE IN THE UNITED STATES ARE PROTECTED FROM THIS "SNAKE OIL" BY THE FDA SUSPENDING DEVICE CERTIFICATION PENDING FORMAL REVIEW OF THESE CHARGES AND A REVIEW OF THE FACTS SURROUNDING THIS AND OTHER CASES. DATES OF USE: ONE MONTH, DIAGNOSIS OR REASON FOR USE: FDA CERTIFIED FOR LUMBAR SPINE PROBLEMS.