MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-23 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical.
[142815564]
(b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[142815565]
It was reported that the device had spontaneously loosened and could not be subsequently re-tightened on a patient. Another device was immediately applied and after achieving arterial occlusion the device made an audible snap and it was found lying on the ground.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00130 |
| MDR Report Key | 8541627 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-23 |
| Date of Report | 2018-12-09 |
| Date of Event | 2018-11-22 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-04-23 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRESPONDER TOURNIQUET |
| Generic Name | NONPNEUMATIC TOURNIQUET |
| Product Code | GAX |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-04-11 |
| Catalog Number | MATR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |