FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE FIT ULTRA SYSTEM
MDR report key: 24693981
·
Received March 25, 2026
Report
- Report Number
- 2124215-2026-16471
- Event Type
- Malfunction
- Date Received
- March 25, 2026
- Date of Event
- March 2, 2026
- Report Date
- May 21, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTN
- UDI-DI
- 00191506007669
- PMA / PMN Number
- K211223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BLOCK G4: THE PREMARKET / 510(K) #S ARE K211223 & K231549. BLOCK H6: DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF SEAL COMPROMISED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN ADVANTAGE FIT ULTRA SYSTEM DEVICE UPON RECEIPT WAS REPORTED AS DAMAGED. THE HEALTHCARE FACILITY PROVIDED PHOTOGRAPHIC EVIDENCE SHOWING DENTS ON THE DEVICE PACKAGING, ALONG WITH CRACKING AND BREAKAGE OF THE PLASTIC BLISTER TRAY PRIOR TO USE. NO PATIENT INVOLVEMENT WAS REPORTED, AND THE DEVICE WAS NOT USED IN A CLINICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269055 | ADVANTAGE FIT ULTRA SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET | OTN | BOSTON SCIENTIFIC CORPORATION | M0068502160 | 0037806486 | 00191506007669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |