N
Patient 1
PMA/510K # PRE-AMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
MAUDE MDR 8115721
- MDR report key
- 8115721
- Report number
- 1820334-2018-03443
- Event key
- 0
- Event type
- 3
- Date received
- 2018-11-29
- 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
- MR. LARRY POOL
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-29 | 0 |
Event Narratives#
D
Patient 1
THE USER FACILITY REPORT # MW5080534 WAS RECEIVED AND THE REPORT SHOWED THE CUSTOMER REPORTED, A PIECE OF THE OPEN-END FLEXI-TIP URETERAL CATHETER SHEARED OFF DURING CASE. IT IS BELIEVED THAT ALL PIECES WERE REMOVED FROM THE PATIENT. THIS IS NOW THE 3RD DEVICE ISSUE WITH THIS PRODUCT. REFERENCE MDR # 1820334-2018-03442 AND MDR# 1820334-2018-03444 FOR THE OTHER DEVICES REPORTED TO HAVE THE SAME ALLEGED MALFUNCTION. NO ADVERSE EVENT HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.