MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-15 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical.
[100452150]
(b)(4) the device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[100452151]
Issue reported: the trauma surgeon who used it is very familiar with the product, having used it extensively both in the hospital and military settings. The case was a major trauma and the surgeon applied the mat t successfully. However, at a certain point he felt the need to tighten the pressure and so he rotated the turnkey again. He admitted that he had never put this much pressure on this product before. What happened after was that the tourniquet suddenly released all of the pressure at once. He is certain that he did not touch the release button. He thought it was a product malfunction so he took another device and did the exact same thing again. Exactly the same thing happened as a result. The patient's condition is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00035 |
| MDR Report Key | 7274401 |
| Date Received | 2018-02-15 |
| Date of Report | 2018-01-25 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-03-20 |
| Date Added to Maude | 2018-02-15 |
| 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 | 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 |
| Generic Name | NONPNEUMATIC TOURNIQUET |
| Product Code | GAX |
| Date Received | 2018-02-15 |
| Returned To Mfg | 2018-02-02 |
| Catalog Number | MATR |
| Lot Number | UNKNOWN |
| 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 | 2018-02-15 |