FDA Adverse Event
Malfunction
Summary report: N
UROVAC BLADDER EVACUATOR
MDR report key: 21965103
·
Received May 5, 2025
Report
- Report Number
- 2124215-2025-28560
- Event Type
- Malfunction
- Date Received
- May 5, 2025
- Date of Event
- April 8, 2025
- Report Date
- May 5, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FFD
- UDI-DI
- 08714729033769
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN THE DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A UROVAC DEVICE WAS ABOUT TO BE USED DURING TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE. REPORTEDLY, UPON OPENING THE PACKAGING THEY SAW A BLACK FLECKS INSIDE THREE UROVACS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF THREE UROVAC DEVICES USED IN THE SAME PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1884395 | UROVAC BLADDER EVACUATOR | EVACUATOR, BLADDER, MANUALLY OPERATED | FFD | BOSTON SCIENTIFIC CORPORATION | M0067301251 | 0035954603 | 08714729033769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |