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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRITON DTS MECHANICAL TRACTION
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TRITON DTS MECHANICAL TRACTION Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem Pain (1994)
Event Date 08/13/2013
Event Type  Injury  
Event Description
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.
 
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Brand Name
TRITON DTS MECHANICAL TRACTION
Type of Device
TRACTION
MDR Report Key4397722
MDR Text Key5308845
Report NumberMW5040029
Device Sequence Number1
Product Code ITH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age46 YR
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