MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-04 for TRITAN DTS manufactured by .
[1914424]
Brain hemorrhage. Dates of use: (b)(6) 2008, 3x weekly. Diagnosis or reason for use: neck disk degeneration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019729 |
| MDR Report Key | 2016341 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-03-04 |
| Date of Event | 2008-02-13 |
| Date Added to Maude | 2011-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRITAN DTS |
| Generic Name | DECOMPRESSION MACHINE |
| Product Code | JFB |
| Date Received | 2011-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2011-03-04 |