MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-28 for SWAT-T manufactured by Tems Solutions.
[4810995]
Soldier was on patrol and was wounded. Bilateral left extremities open fractures. Soft_t successfully applied to left thigh. Attempted application of 2 different swat-ts (both new), both torn. Switched to crt tourniquet, successfully applied x2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037993 |
| MDR Report Key | 4055895 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-07-15 |
| Date Added to Maude | 2014-09-04 |
| 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 |
| 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 | SWAT-T |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2014-08-28 |
| Model Number | SWAT-T |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEMS SOLUTIONS |
| Manufacturer Address | ABINGDON |
| Brand Name | SWAT-T |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2014-08-28 |
| Model Number | SWAT-T |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TEMS SOLUTIONS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening | 2014-08-28 |