FDA.reportPublic FDA data

MAUDE MDR 1913307

MDR report key
1913307
Report number
MW5018327
Event key
0
Event type
3
Date of event
2009-10-19
Date received
2010-10-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRX9000NONEAXIOMITH Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-10-2201. S

Event Narratives#

D

Patient 1

I WAS DUPED BY A LOCAL CHIROPRACTOR THAT HAD ADVERTISED IN OUR LOCAL NEWSPAPER ABOUT THE DRX9000. AFTER 10TH TREATMENTS, I WASN'T GETTING ANY BETTER AND BY THE 20TH TREATMENT, I HAD TO GO TO THE LOCAL REHAB TREATMENT CENTER BECAUSE EVERY STEP I TOOK WAS EXTREME PAIN. UP TO THIS DAY, I STILL HAVE A PROBLEM LAYING DOWN AND SITTING FOR A LITTLE WHILE WHICH I NEVER HAD A PROBLEM WITH BEFORE THE TREATMENTS WITH THE SRX9000. THE MACHINE I THINK IS JUST A MODERN VERSION OF A MEDIVAL TORTURE DEVICE. DATES OF USE: (B)(6) 2009. DIAGNOSIS OR REASON FOR USE: PINCHED NERVE - CHIROPRACTOR DIAGNOSIS.