N
Patient 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
MAUDE MDR 7479861
- MDR report key
- 7479861
- Report number
- 3011137372-2018-00110
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-04-08
- Date received
- 2018-05-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 108
- 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 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-02 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING A MOTORCYCLE ACCIDENT THE EMS WAS TRYING TO STOP THE BLEEDING ON THE PATIENT. WHEN HE BEGAN TO WIND THE TOURNIQUET, IT SNAPPED AND WAS UNABLE TO STOP THE BLEEDING, AND A BELT WAS USED INSTEAD. THE PATIENT ENDED UP WITH A LEFT BELOW THE KNEE AMPUTATION.
N
Patient 1
(B)(4). A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. 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 COULD NOT BE PERFORMED SINCE A CORRECT LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. 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.
D
Patient 1
IT WAS REPORTED THAT DURING A MOTORCYCLE ACCIDENT THE EMS WAS TRYING TO STOP THE BLEEDING ON THE PATIENT. WHEN HE BEGAN TO WIND THE TOURNIQUET, IT SNAPPED AND WAS UNABLE TO STOP THE BLEEDING, AND A BELT WAS USED INSTEAD. THE PATIENT ENDED UP WITH A LEFT BELOW THE KNEE AMPUTATION.