FDA Adverse Event
Injury
Summary report: N
BIOPROTECT BALLOON IMPLANT SYSTEM
MDR report key: 23249601
·
Received October 8, 2025
Report
- Report Number
- 3012602431-2025-00089
- Event Type
- Injury
- Date Received
- October 8, 2025
- Date of Event
- August 13, 2025
- Report Date
- October 8, 2025
- Manufacturer
- BIOPROTECT LTD
- Product Code
- OVB
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
MFR REPORT #: 3014285231-2025-00009. IT WAS REPORTED TO BIOPROTECT LTD. ON (B)(6) 2025 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2025 AND COMPLETED AS EXPECTED. FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF NOT BEING ABLE TO VOID URINE. A FOLEY CATHETER WAS PLACED AND THE PATIENT WAS DISCHARGED. THE CATHETER WAS REMOVED ON (B)(6) 2025, AND THE SYMPTOMS WERE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2509794 | BIOPROTECT BALLOON IMPLANT SYSTEM | BIOPROTECT BALLOON IMPLANT SYSTEM | OVB | BIOPROTECT LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |