FDA Adverse Event
Other
Summary report: N
ESCAPE
MDR report key: 16673273
·
Received April 4, 2023
Report
- Report Number
- 16673273
- Event Type
- Other
- Date Received
- April 4, 2023
- Date of Event
- August 4, 2021
- Report Date
- August 19, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FFL
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
WHILE SURGEON REMOVING DEVICE FROM PATIENT THE DEVICE BROKE INSIDE OF THE PATIENT¿S URETHRA AND WAS REMOVED BY THE SURGEON. ALL PIECES WERE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1086898 | ESCAPE | DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | BOSTON SCIENTIFIC CORPORATION | M0063902010 | 27542688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |