FDA Adverse Event
Malfunction
Summary report: N
SOLYX BLUE
MDR report key: 23989037
·
Received January 7, 2026
Report
- Report Number
- 2124215-2026-00894
- Event Type
- Malfunction
- Date Received
- January 7, 2026
- Date of Event
- October 20, 2025
- Report Date
- January 7, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PAH
- UDI-DI
- 08714729961901
- PMA / PMN Number
- K081275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULTY ADVANCING THE DEVICE THROUGH THE PATIENT'S TISSUE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE SOLYX DEVICE THROUGH THE PATIENT'S TISSUE, WHICH LED TO THE MESH DEFORMING. ANOTHER SOLYX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED FOLLOWING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51761 | SOLYX BLUE | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA | PAH | BOSTON SCIENTIFIC CORPORATION | M0068507010 | 0037232922 | 08714729961901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |