MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-19 for MAT TOURNIQUET US PATENT 7582102 manufactured by Pying Medical.
[15358400]
Paramedic applied a mat tourniquet to an arterial bleeding patient who was stabbed. After 4-5 minutes of being applied the strap portion that is secured to the cradle portion broke loose resulting in the patient losing a significant amount of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038304 |
| MDR Report Key | 4114575 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-10 |
| Date of Event | 2014-09-07 |
| Date Added to Maude | 2014-09-25 |
| 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 | PARAMEDIC |
| 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 | MAT TOURNIQUET |
| Generic Name | MAT TOURNIQUET |
| Product Code | GAX |
| Date Received | 2014-09-19 |
| Model Number | US PATENT 7582102 |
| ID Number | NSN 6515-01-538-2207 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYING MEDICAL |
| Manufacturer Address | 210-13480 CRESTWOOD PLACE RICHMOND, BC V662J9 CA V66 2J9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2014-09-19 |