N
Patient 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
MAUDE MDR 7828186
- MDR report key
- 7828186
- Report number
- 3011137372-2018-00253
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-08-15
- Date received
- 2018-08-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JASMINE BROWN
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
- Phone
- 919-919-9193
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MATRESPONDER TOURNIQUET | NONPNEUMATIC TOURNIQUET | PYNG MEDICAL | GAX | MATR | 952 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-08-29 | 0 |
Event Narratives#
D
Patient 1
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.
N
Patient 1
(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.
D
Patient 1
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.