MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-12 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical.
[102198791]
(b)(4). The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[102198792]
It was reported that after the tourniquet was placed, the tensioning strap was tightened with the twist lock. Before the arterial bleeding in the forearm was stopped, the tension strap tore at the suture to the corpus of the tourniquet and was therefore useless. A new tourniquet was used to stop the bleeding. The patient's current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00065 |
| MDR Report Key | 7330960 |
| Date Received | 2018-03-12 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-04-05 |
| Date Added to Maude | 2018-03-12 |
| 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 | PARAMEDIC |
| 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 | 0 |
| Brand Name | MATRESPONDER TOURNIQUET |
| Product Code | GAX |
| Date Received | 2018-03-12 |
| Returned To Mfg | 2018-03-26 |
| Catalog Number | MATR |
| Lot Number | UNKNOWN |
| 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 | 2018-03-12 |