MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-24 for MAT MECHANICAL ADVANTAGE TOURNIQUET MAT01 manufactured by Pyng Medical Corp..
[19250365]
The strap came away from the housing when using a mat mechanical advantage tourniquet. (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[19328951]
There was evidence of overtightening of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615387-2009-00039 |
| MDR Report Key | 1547217 |
| Report Source | 05 |
| Date Received | 2009-11-24 |
| Date of Report | 2009-11-23 |
| Date of Event | 2009-11-01 |
| Date Mfgr Received | 2009-11-02 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2010-06-07 |
| 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 | 3 |
| 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, BRITISH COLUMBIA V6V 2E9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V 2E9 |
| Manufacturer Phone | 3037964 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAT MECHANICAL ADVANTAGE TOURNIQUET |
| Generic Name | GAX - TOURNIQUET, NONPNEUMATIC |
| Product Code | GAX |
| Date Received | 2009-11-24 |
| Returned To Mfg | 2009-11-09 |
| Model Number | MAT01 |
| Lot Number | 535 |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-11-24 |