AXIOM WORLDWIDE DRX-9000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-03 for AXIOM WORLDWIDE DRX-9000 manufactured by Axiom Worldwide.

Event Text Entries

[719812] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5003633
MDR Report Key908350
Date Received2007-09-03
Date of Report2007-09-03
Date of Event2006-09-18
Date Added to Maude2007-09-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAXIOM WORLDWIDE
Generic NameDRX-9000
Product CodeITH
Date Received2007-09-03
Model NumberDRX-9000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key887412
ManufacturerAXIOM WORLDWIDE
Manufacturer AddressTAMPA FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2007-09-03

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