FDA Adverse Event
Malfunction
Summary report: N
UROVAC BLADDER EVACUATOR
MDR report key: 21961805
·
Received May 5, 2025
Report
- Report Number
- 2124215-2025-28558
- 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 3 UROVACS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF THREE UROVAC DEVICES USED IN THE SAME PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1820089 | UROVAC BLADDER EVACUATOR | EVACUATOR, BLADDER, MANUALLY OPERATED | FFD | BOSTON SCIENTIFIC CORPORATION | M0067301251 | 0035954603 | 08714729033769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |