MEDX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-08 for MEDX manufactured by Medx Ocala.

Event Text Entries

[4016859] Reporter stated in email to medex on (b)(4) 2013, patient was participating in isometric testing 0-48 degrees. Testing was completed without incident. The following day patient complained without incident. The following day patient complained of some muscular soreness, suggesting doms. Pain intensified to disabling over the course of (b)(6) 2013 and required medical review. X-ray performed showed no fracture. Ct (b)(6) 2013, showed fracture (involving the inferior endplate of l4 with mild retropulsed bony fragments extending 3mm in to the spinal canal.
Patient Sequence No: 1, Text Type: D, B5


[11338010] This machine was manufactured by medx in 1997. It was purchased as used by the current owner in approx 2007. Reporter stated that the device has been use for 6 years and that 130 patients use the device every week in a clinical setting. The reporter stated that this was the only problem that they had with the device. The manufacturer recommended that the machine be sent back to medx for evaluation, however, the owner has declined. The manufacturer then recommended that the device be taken out of service until they could verify that it was functioning properly. The manufacturer has received no further communication from the reporter at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1051095-2013-00002
MDR Report Key3467488
Report Source07
Date Received2013-11-08
Date of Report2013-10-30
Date of Event2013-09-17
Date Mfgr Received2013-10-09
Device Manufacturer Date1997-01-01
Date Added to Maude2013-11-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMEDX HOLDINGS
Manufacturer Street839 NW 25TH AVE.
Manufacturer CityOCALA FL 34475
Manufacturer CountryUS
Manufacturer Postal34475
Manufacturer Phone3523512005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDX
Generic NameLUMBAR EXTENSION MACHINE
Product CodeION
Date Received2013-11-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDX OCALA
Manufacturer AddressFL US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2013-11-08

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