MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-08-31 for MAT MECHANICAL ADVANTAGE TOURNIQUET MAT01 manufactured by Pyng Medical Corp..
[17718468]
Male pt had extensive avulsions and lacerations on his lower leg from getting caught up in a boat propeller. The wound was initially dressed with a towel, but was soaking through. There were 2 wounds approximately 8-10 inches long and approximately 4 inches wide, one on the medial side of the left lower leg, the other on the lateral side of the left lower leg. The mat tourniquet was applied approximately 3 inches above the knee. Upon tightening, the medic noticed that the venous bleeding had stopped, but the arterial bleeding was still present. The medic continued to tighten the tourniquet and as arterial bleeding was slowing down, the web strapping slid through the buckle. The medic tried to tighten the strap through the buckle again and attempted to tighten the tourniquet again but it happened again. At this point, the "(b)(6)" was landing so the medic packed the wound with trauma dressing. The (b)(6) nurse exposed and clamped off the arteries. The pt was ok. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17982861]
Still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615387-2010-00011 |
| MDR Report Key | 1825951 |
| Report Source | 08 |
| Date Received | 2010-08-31 |
| Date of Report | 2010-08-31 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2010-08-17 |
| Date Added to Maude | 2012-03-13 |
| 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, BC V6V2E9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V 2E9 |
| Manufacturer Phone | 3037964 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAT MECHANICAL ADVANTAGE TOURNIQUET |
| Product Code | GAX |
| Date Received | 2010-08-31 |
| Model Number | MAT01 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL CORP. |
| Manufacturer Address | RICHMOND, BC V6V2E9 CA V6V 2E9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-31 |