FDA Adverse Event
Malfunction
Summary report: N
BIOPROTECT BALLOON IMPLANT SYSTEM
MDR report key: 24601687
·
Received March 15, 2026
Report
- Report Number
- 3012602431-2026-00031
- Event Type
- Malfunction
- Date Received
- March 15, 2026
- Date of Event
- January 23, 2026
- Report Date
- March 15, 2026
- Manufacturer
- BIOPROTECT LTD
- Product Code
- OVB
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
MFR REPORT #: 3014285231-2026-00001. 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 |
|---|---|---|---|---|---|---|---|
| 662680 | BIOPROTECT BALLOON IMPLANT SYSTEM | BIOPROTECT BALLOON IMPLANT SYSTEM | OVB | BIOPROTECT LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |