FDA Adverse Event
Injury
Summary report: N
BIOPROTECT BALLOON IMPLANT SYSTEM
MDR report key: 23765774
·
Received December 10, 2025
Report
- Report Number
- 3014285231-2025-00012
- Event Type
- Injury
- Date Received
- December 10, 2025
- Date of Event
- November 11, 2025
- Report Date
- December 10, 2025
- Manufacturer
- BIOPROTECT LTD.
- Product Code
- OVB
- UDI-DI
- 7290014878020
- 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
ON (B)(6) 2025, IT WAS REPORTED TO BIOPROTECT LTD ABOUT A PATIENT COMPLAINING ON RECTAL PAIN. THE PATIENT UNDERWENT DIGITAL RECTAL EXAMINATION (DRE), CT SCAN AND OBSERVATIONAL COLONOSCOPY WITH NO EVIDNACE OF RECTAL INJURY OR OTHER FINDINGS.
Description of Event or Problem · 0
ON (B)(6) 2025, IT WAS REPORTED TO BIOPROTECT LTD ABOUT A A PATIENT COMPLAINING ON RECTAL PAIN. THE PATIENT UNDERWENT DIGITAL RECTAL EXAMINATION (DRE), CT SCAN AND OBSERVATIONAL COLONOSCOPY WITH NO EVIDNACE OF RECTAL INJURY OR OTHER FINDINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1990481 | BIOPROTECT BALLOON IMPLANT SYSTEM | BIOPROTECT BALLOON IMPLANT SYSTEM | OVB | BIOPROTECT LTD. | 7290014878020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |