MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-02 for MAT; MECHANICAL ADVANTAGE TOURNIQUET manufactured by Pyng Medical Corp..
[1616200]
During a training session the buckle locking the strap into place slipped causing the device to not stay tight around the arm. No pt was involved. Pyng (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8574045]
The device has not been returned to pyng medical.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615387-2010-00005 |
| MDR Report Key | 1714753 |
| Report Source | 05 |
| Date Received | 2010-06-02 |
| Date of Report | 2010-06-02 |
| Date of Event | 2010-05-12 |
| Date Mfgr Received | 2010-05-12 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2011-01-31 |
| 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 |
| 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 |
| Manufacturer Phone | 3037964 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAT; MECHANICAL ADVANTAGE TOURNIQUET |
| Generic Name | TOURNIQUET, NONPNEUMATIC |
| Product Code | GAX |
| Date Received | 2010-06-02 |
| Model Number | MAT |
| Lot Number | 933 |
| 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, B.C. V6V2E9 CA V6V 2E9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-02 |