FDA Adverse Event
Injury
Summary report: N
BIOPROTECT BALLOON IMPLANT SYSTEM
MDR report key: 23249138
·
Received October 8, 2025
Report
- Report Number
- 3012602431-2025-00088
- Event Type
- Injury
- Date Received
- October 8, 2025
- Date of Event
- August 15, 2025
- Report Date
- September 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
IT WAS REPORTED TO BIOPROTECT LTD. ON 15-AUG-2025 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2025. FOLLOWING PROCEDURE COMPLETION, THE PATIENT REPORTED ON DISCOMFORT IN THE PERINEAL AREA. THE PHYSICIAN PARTIALLY ASPIRATED THE BALLOON AND THE SYMPTOMS WERE RELIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2584404 | BIOPROTECT BALLOON IMPLANT SYSTEM | BIOPROTECT BALLOON IMPLANT SYSTEM | OVB | BIOPROTECT LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |