N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
MAUDE MDR 8598774
- MDR report key
- 8598774
- Report number
- 1018233-2019-02423
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-02-19
- Date received
- 2019-05-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 109
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- YONIC ANDERSON
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD? X-FORCE? BALLOON DILATION CATHETER | X-FORCE | C.R. BARD, INC. (COVINGTON) -1018233 | EZN | 998604 | 998604 | BMBXFM09 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-10 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT AFTER INFLATING AND DEFLATING THE CATHETER, THE PATIENT ALLEGEDLY EXPERIENCED A LONGITUDINAL TEAR OF ABOUT ONE CENTIMETER IN THE BACK SECTION OF THE URETER. THE EXTENT OF INTERVENTION THAT WAS PERFORMED TO REPAIR THE URETER IS CURRENTLY UNKNOWN.