MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-01 for TRITON TRT-200 manufactured by Djo, Llc.
[2073910]
The patient was moving from a chair to a high low table. The table was elevated, so the patient could remain in the seated position. As she sat on the table, the elevated area came out of the grooves and fell flat. This startled the patient. She felt her 3rd and 4th digits may have been pinched. She was given ice and reported no pain at the end of the treatment session. There were no cuts or bruises when she left. Medwatch form fda 3500a was filed with fda by hospital. Event occurred on (b)(6) 2011. (b)(6) received copy of hospital filed medwatch on (b)(6) 2011. The information has not been corroborated. Investigation pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2011-00006 |
| MDR Report Key | 2156040 |
| Report Source | 06 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-06-30 |
| Date of Event | 2011-02-17 |
| Date Added to Maude | 2011-07-13 |
| 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 STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607343052 |
| Manufacturer G1 | CHATTANOOGA GROUP |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRITON TRT-200 |
| Generic Name | TRACTION TABLE |
| Product Code | ITH |
| Date Received | 2011-07-01 |
| Model Number | TRT-200 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-01 |