FDA Adverse Event
Injury
Summary report: N
BIOPROTECT BALLOON IMPLANT SYSTEM
MDR report key: 22304410
·
Received June 22, 2025
Report
- Report Number
- 3014285231-2025-00003
- Event Type
- Injury
- Date Received
- June 22, 2025
- Date of Event
- May 25, 2025
- Report Date
- May 22, 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 (B)(6) 2025 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA. WHEN THE PATIENT WOKE UP, HE COMPLAINED ABOUT RECTAL PAIN AND BLOODY DISCHARGE, WHICH RESOLVED POSTOPERATIVELY. THE PATIENT WAS ADMITTED OVERNIGHT AND WAS DISCHARGED THE FOLLOWING DAY WITH PAIN RELIEVING MEDICATION. THE FOLLOWING DAY, A CT SCAN SHOWED A HEMATOMA UNDER THE BASE OF THE PROSTATE AND SVS. CURRENTLY, THE PATIENT IS DOING FINE; HE WILL START RT AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1262274 | BIOPROTECT BALLOON IMPLANT SYSTEM | BIOPROTECT BALLOON IMPLANT SYSTEM | OVB | BIOPROTECT LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization |