MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-08-02 for TRITON DTS 2841 manufactured by Dj Orthopedics De Mexico.
[1432863]
On (b)(6) 2010, pt reported an injury she sustained using the triton dts pkg. Per the pt, the location treated was her lower back and she was treated twice, once at 70 lbs for 10 mins and two days later at 75 lbs for 20 mins. Following the treatments, she was barely able to walk due to excruciating pain in the lower back radiating to the legs. In an email dated (b)(6) 2010, the pt stated "in a physical exam after suffering from pains as a result of traction therapy with triton dts, my health care provider stated that my lower back was inflamed. She gave me anti-inflammatory patches and prescription strength pain killers. The mri revealed bulged discs in the lumbar spine, not previously seen in any mri studies. The onset of pain was directly correlated with traction therapy with triton dts. " in a letter dated (b)(6) 2010, djo was notified by the fda of a medwatch form ((b)(4)) filed on (b)(6) 2010 for the triton dts. Pt had back injuries from a vehicle collision and was receiving physical therapy. Info provided in the medwatch report and the dates of the event suggest that both the medwatch and the pt report above are the same incident.
Patient Sequence No: 1, Text Type: D, B5
[8705258]
(b)(4), dated (b)(4) 2010 received from fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2010-00021 |
| MDR Report Key | 1836192 |
| Report Source | 00 |
| Date Received | 2010-08-02 |
| Date of Report | 2010-05-21 |
| Date of Event | 2010-04-23 |
| Date Mfgr Received | 2010-05-21 |
| Date Added to Maude | 2012-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA B.C. 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRITON DTS |
| Generic Name | TRACTION UNIT |
| Product Code | ITH |
| Date Received | 2010-08-02 |
| Model Number | 2841 |
| Catalog Number | 2841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJ ORTHOPEDICS DE MEXICO |
| Manufacturer Address | TIJUANA B.C. 22244 MX 22244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-02 |