FDA Adverse Event
Injury
Summary report: N
SOLYX BLUE
MDR report key: 23560989
·
Received November 14, 2025
Report
- Report Number
- 2124215-2025-81370
- Event Type
- Injury
- Date Received
- November 14, 2025
- Date of Event
- October 15, 2025
- Report Date
- November 14, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PAH
- UDI-DI
- 08714729961901
- PMA / PMN Number
- K081275
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF VAGINAL PERFORATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING THE PROCEDURE, THE OBTURATOR WAS NOT PROPERLY ALIGNED, RESULTING IN A VAGINAL WALL PERFORATION DURING SLING MANIPULATION. THE IMPLANTED MESH WAS IMMEDIATELY REMOVED, AND A NEW SOLYX SLING WAS REINSERTED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED FOLLOWING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2789181 | SOLYX BLUE | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA | PAH | BOSTON SCIENTIFIC CORPORATION | M0068507010 | 0036774955 | 08714729961901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |