FDA Adverse Event
Malfunction
Summary report: N
SPATZ3 ADJUSTABLE BALLOON SYSTEM
MDR report key: 24427476
·
Received February 24, 2026
Report
- Report Number
- 3012638928-2026-03493
- Event Type
- Malfunction
- Date Received
- February 24, 2026
- Date of Event
- January 28, 2026
- Report Date
- January 29, 2026
- Manufacturer
- SPATZ FGIA INC.
- Product Code
- LTI
- UDI-DI
- 860005178810
- PMA / PMN Number
- P190012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
HYPERINFLATION. THE PATIENT CONTACTED US ON (B)(6) 2025 REPORTING BLUE URINE. SHE WAS INSTRUCTED TO ATTEND THE HIC SINCE DR. (B)(6) WAS ON VACATION, AND THE FOLLOWING DAY SHE WAS SEEN BY DR. (B)(6), WHO REMOVED THE COMPLETELY EMPTY GASTRIC BALLOON, WHICH HAD MIGRATED TO THE PROXIMAL JEJUNUM, VIA ENDOSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493003 | SPATZ3 ADJUSTABLE BALLOON SYSTEM | GASTRIC BALLOON | LTI | SPATZ FGIA INC. | A-SP3-03K | 860005178810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |