FDA Adverse Event
Injury
Summary report: N
BIOPROTECT BALLOON IMPLANT SYSTEM
MDR report key: 23836799
·
Received December 18, 2025
Report
- Report Number
- 3014285231-2025-00014
- Event Type
- Injury
- Date Received
- December 18, 2025
- Date of Event
- November 19, 2025
- Report Date
- December 18, 2025
- Manufacturer
- BIOPROTECT LTD.
- Product Code
- OVB
- PMA / PMN Number
- K222972
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO BIOPROTECT LTD. ON 19-NOVEMBER-2025 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS DONE UNDER MONITORED ANESTHESIA CARE. ONE DAY FOLLOWING THE BALLOON IMPLANTATION PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PAIN, NAUSEA, AND VOMITING. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED A HEMATOMA ADJACENT TO THE URETHRA AND THE PATIENT REPORTED ON URINARY RETENTION. THE RETENTION WAS RESOLVED FOLLOWING CATHETER PLACEMENT. THE PATIENT IS CURRENTLY STABLE AND IS EXPECTED TO BEGIN RADIATION TREATMENTS AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2274991 | BIOPROTECT BALLOON IMPLANT SYSTEM | BIOPROTECT BALLOON IMPLANT SYSTEM | OVB | BIOPROTECT LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |