FDA Adverse Event
Malfunction
Summary report: N
SOLYX SIS SYSTEM
MDR report key: 1760081
·
Received July 16, 2010
Report
- Report Number
- 3005099803-2010-03185
- Event Type
- Malfunction
- Date Received
- July 16, 2010
- Date of Event
- June 24, 2010
- Report Date
- June 24, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MESH FRAYED NEAR THE CENTER, CURLED UP AND WOULD NOT LIE FLAT DURING THE PLACEMENT OF THE SECOND SIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SOLYX SIS SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLYX SIS SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068507000 | 0ML9040902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |