MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-31 for MAT MECHANICAL ADVANTAGE TOURNIQUET MAT01 manufactured by Pyng Medical Corp..
[1589087]
Strap separated from the device during a training session. The mat is intended for single use. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8693684]
The device was being used during a training session. It was being demonstrated to a trainee. The mat is intended for single use. It is not known how many times the device was used before the strap separated. According to 21cfr803 22 (b) (1) an alleged device-related adverse event did not occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615387-2010-00010 |
| MDR Report Key | 1825950 |
| Report Source | 05 |
| Date Received | 2010-08-31 |
| Date of Report | 2010-08-31 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2010-08-04 |
| 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 | 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, BC 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 |
| Product Code | GAX |
| Date Received | 2010-08-31 |
| Model Number | MAT01 |
| 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 |