MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2010-11-30 for MAT MECHANICAL ADVANTAGE TOURNIQUET MAT01 manufactured by Pyng Medical Corp..
[22053785]
The device has not been returned to pyng medical corp for formal evaluation; however, the complainant mentioned that the device was used on 3 different subjects. The mat device is a single use device. While no formal conclusions can be drawn at this time, the device was not being used according to the intended use (labeling).
Patient Sequence No: 1, Text Type: N, H10
[22095250]
During a training session of the ski patrol at squaw valley ski area, the trainer applied the mat tourniquet to three people. On the third test subject, during the tightening of the tourniquet, as reported by the complainant, "the mat completely failed" (which would prevent the device from operating as intended). Note: the mat device is a single use device. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615387-2010-00018 |
| MDR Report Key | 1931854 |
| Report Source | 00,06 |
| Date Received | 2010-11-30 |
| Date of Report | 2010-11-30 |
| Date of Event | 2010-11-16 |
| Date Mfgr Received | 2010-11-16 |
| Date Added to Maude | 2011-02-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | #7, 13511 CRESTWOOD PL |
| Manufacturer City | RICHMOND, B.C. V6V 2E9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V 2E9 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAT MECHANICAL ADVANTAGE TOURNIQUET |
| Product Code | GAX |
| Date Received | 2010-11-30 |
| Model Number | MAT01 |
| Lot Number | UNK |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL CORP. |
| Manufacturer Address | RICHMOND, B.C. V6V2E9 CA V6V 2E9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-30 |