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 2018-09-25 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical.
[121605376]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[121605377]
It was reported that the buckle lacked the tactile click when seated into place and came off the buckle when tightened down over the patient's leg by the spin wheel. The patient's condition is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00270 |
| MDR Report Key | 7905815 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-07-14 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-09-25 |
| 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 | 2018-09-25 |
| Returned To Mfg | 2018-09-27 |
| Catalog Number | MATR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |