MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2011-05-26 for MAT MECHANICAL ADVANTAGE TOURNIQUET MAT01 manufactured by Pyng Medical Corp..
[2131309]
Failure of 3 mat tourniquets. Female pt with compression injuries to leg (due to tree fall). During extrication and transport, the medic attempted to use multiple mat tourniquets to slow bleeding. First and second device were inoperable. According to maude event report (received from fda) the strap on devices slipped and would not remain tight. One device would not release and the strap was ultimately cut. With the second device the strap released/separated from the mat unit. The strap on the third device slipped and would not remain as tight as medic wanted; however, it was used. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9207402]
At the timing of reporting this mdr, the mat devices have not been returned to pyng. One of the units was discarded by the paramedic. A request for the return of the other two mat devices was made to the initial reporter; however, they have not been received. An initial eval was performed on a mat device from stock at pyng. No conclusions can be drawn at this time. Note: this event was reported to fda per voluntary report number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615387-2011-00002 |
| MDR Report Key | 2185090 |
| Report Source | 00,05 |
| Date Received | 2011-05-26 |
| Date of Report | 2011-05-25 |
| Date of Event | 2011-03-13 |
| Date Mfgr Received | 2011-04-26 |
| Date Added to Maude | 2012-04-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 V6V 2E9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V 2E9 |
| Manufacturer Phone | 3037964 |
| 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 | 2011-05-26 |
| Model Number | MAT01 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-05-26 |