MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-12-19 for TRITON TRE-24 manufactured by Chattanooga Group.
[1044998]
The patient was receiving treatment on the table when the table head section released from the set position. The action lowered the patient's head. The lowering action injured the patient.
Patient Sequence No: 1, Text Type: D, B5
[8205835]
The investigation, device evaluation, and any additional findings will be provided upon conclusion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00375 |
| MDR Report Key | 1295529 |
| Report Source | 00 |
| Date Received | 2008-12-19 |
| Date of Report | 2008-12-01 |
| Date of Event | 2007-10-25 |
| Date Mfgr Received | 2008-12-01 |
| Date Added to Maude | 2009-06-17 |
| 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 Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS ROAD |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRITON TRE-24 |
| Product Code | INQ |
| Date Received | 2008-12-19 |
| Model Number | TRE-24 |
| Catalog Number | TRE-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-19 |