FDA Adverse Event
Injury
Summary report: N
BIOPROTECT BALLOON IMPLANT SYSTEM
MDR report key: 24388754
·
Received February 19, 2026
Report
- Report Number
- 3014285231-2026-00001
- Event Type
- Injury
- Date Received
- February 19, 2026
- Date of Event
- January 23, 2026
- Report Date
- February 19, 2026
- Manufacturer
- BIOPROTECT LTD.
- Product Code
- OVB
- PMA / PMN Number
- K222972
- Product Problem
- 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 (B)(6) 2026 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2025 AND COMPLETED AS EXPECTED. ON (B)(6) 2026 THE PATIENT UNDERWENT CT THAT SHOWED BALLOON SIGNIFICANT DEFLATION. ON (B)(6) 2026, ANOTHER SPACER WAS PLACED UNDER LOCAL ANESTHESIA. THE PATIENT IS DOING FINE WITH NO CLINICAL SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449710 | BIOPROTECT BALLOON IMPLANT SYSTEM | BIOPROTECT BALLOON IMPLANT SYSTEM | OVB | BIOPROTECT LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |