TRITON DTS UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-11 for TRITON DTS UNK manufactured by Chattanooga Group.

Event Text Entries

[17072147] Chattanooga group triton dts traction machine. Triton dts adverse event report: due to back injuries from a vehicle collision in (b) (6) 2009, i was receiving physical therapy. The physical therapist had a brand-new traction machine, the triton dts. She stated this would treat problems in the spine. She applied treatment on my lumbar spine and pelvis. After the first session, in which she applied weight on my spine by pulling it via machine, i couldn't walk normal. She proceeded with exercises. The next day i experienced more pain. In the second session, which was 2 days after the first session, she did the same treatment. By evening, i had excruciating pain in my lower spine, radiating to my legs, and i could barely walk. My pelvic area and my lower spine felt like they had been seriously strained. I told the therapist about it. She said it was due to my pre-existing symptoms. I, however, feel it was due to traction. I asked her how much weight she had applied. She stated it was "only" 35 pounds in both sessions. I have still pain. I stopped the traction therapy. I would like to ask you if any other patient-s- have filed a report or complaint with your organization regarding adverse events with triton dts traction machines. Also, may i ask you to please inform me what the correct setting is when the patient has pain from the first treatment? As mentioned above, the therapist started me with 35 pounds, and in the second session, she applied the same weight. Do you know what the starting setting should be, and how much weight should be applied, for what condition, and for how long? The therapist explained nothing to me, therefore, i have no information at hand. Triton dts; treatment dates: (b) (6) and (b) (6), 2010. Dates of use: (b) (6) 2010. Diagnosis or reason for use: unknown to patient. Event abated after use stopped or dose reduced:: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5015947
MDR Report Key1691094
Date Received2010-05-11
Date of Report2010-05-11
Date of Event2010-04-23
Date Added to Maude2010-05-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRITON DTS
Generic NameTRACTION MACHINE
Product CodeITH
Date Received2010-05-11
Model NumberDTS
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCHATTANOOGA GROUP
Manufacturer AddressCA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-05-11

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