DRX9000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-28 for DRX9000 manufactured by Unk.

Event Text Entries

[2274178] Dr (b)(6) at the (b)(6) claims to have a machine the (b)(4) that will correct any back problem. Specifically in this case my (b)(6) father who fell from a 2nd floor onto a 2 by 4 on a concrete floor, breaking his back. My father has had trouble walking the past 10 years and had constantly gotten worse. My father found an ad in the paper by (b)(6) and made an appointment. I was present at this consultation where mr (b)(6) claimed that by seeing my fathers mri he could tell whether he would be able to cure my father. His exact words were, in 6 to 9 weeks my father would be walking 3-4 miles no problem. On the 2nd consultation, i had a lot of questions and as i began, mr (b)(6) immediately go defensive and refused to answer my questions. I was thrown out of the office. The next day this fast talking quack had my father convinced he would walk without pain in little to no time. My father began this process with this machine on wednesday (b)(6) 2011 and by thursday (b)(6) 2011, my father could no longer walk. He was carried to the thanksgiving table. Mr (b)(6) told my brother that it is normal for the pt to get worse before they get better. I do not believe a word he is saying and i believe this machine is being mis-used and people are given false hope by someone who has fleeced (b)(6) from an elderly man wanting to be free of pain and enjoy life. Instead i see him within a short span of time (much shorter since the use of this machine) in a wheelchair or worse.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5023258
MDR Report Key2356721
Date Received2011-11-28
Date of Report2011-11-28
Date of Event2011-11-16
Date Added to Maude2011-12-05
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 FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDRX9000
Generic NameDRX9000
Product CodeITH
Date Received2011-11-28
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit 2011-11-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.