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 2018-08-29 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical.
[118616832]
(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
[118616833]
It was reported that two mat green tourniquet devices snapped while the paramedic attempted to tension them on a trauma patient who suffered a compound fracture and lacerated femoral artery. The patient's condition is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
[122094109]
(b)(4). A review of the release documentation showed the reported lot passed all acceptance criteria. The ifu provided with this product notifies the user to reset the tourniquet before each application. Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
Patient Sequence No: 1, Text Type: N, H10
[122094110]
It was reported that two mat green tourniquet devices snapped while the paramedic attempted to tension them on a trauma patient who suffered a compound fracture and lacerated femoral artery. The patient's condition is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00254 |
| MDR Report Key | 7828287 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-08-29 |
| 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 | 2018-08-29 |
| Catalog Number | MATR |
| Lot Number | 952 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-08-29 |