TRITON DTS MECHANICAL TRACTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-01 for TRITON DTS MECHANICAL TRACTION manufactured by .

Event Text Entries

[5308845] The adverse event occurred at the chiropractic office of (b)(6) on (b)(6) 2013. It was setup on a mechanical traction device which i believe to be the triton dts for a lumbar therapy session. After being strapped on the table, the personnel proceeded with a pre-program lumbar traction treatment. I was in the treatment for about 10 mins when the personnel came back to check on me. He mentioned i was not strapped properly since the harness was riding up my chest and proceeded to manually release the strap that was connected to me. Right after he released the connected strap, i felt the most excruciating pain in my lower back which i never experienced before. It felt like my lower body was just separated in two pieces. He proceeded to add some tension to my lower back by pulling on the traction attachment piece. The pain was excruciating. A doctor come over and started massaging my lower back sine i couldn't feel my legs. He then stretched the lower back area until i started getting some feelings back to the area. I have had complications from this injury ever since. I want to ensure that this kind of injury doesn't occur to anyone in the future.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040029
• MDR Report Key: 4397722
• Date Received: 2015-01-01
• Date of Report: 2015-01-01
• Date of Event: 2013-08-13
• Date Added to Maude: 2015-01-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRITON DTS MECHANICAL TRACTION
• Generic Name: TRACTION
• Product Code: ITH
• Date Received: 2015-01-01
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2015-01-01