FDA Adverse Event
Injury
Summary report: N
SOLYX SIS SYSTEM
MDR report key: 2880114
·
Received December 19, 2012
Report
- Report Number
- 3005099803-2012-06252
- Event Type
- Injury
- Date Received
- December 19, 2012
- Report Date
- November 29, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081275
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED LOT NUMBER, 0ML9042801, COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS IMPLANTED ON (B)(6), 2009.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URINARY PROBLEMS, DYSPAREUNIA, MESH PROTRUSION, PELVIC PAIN AND DISCOMFORT.ACCORDING TO THE PHYSICIAN'S OFFICE, NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED FOLLOWING THE PROCEDURE.ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLYX SIS SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |