FDA Adverse Event
Injury
Summary report: N
SOLYX SIS SYSTEM
MDR report key: 2991199
·
Received March 6, 2013
Report
- Report Number
- 3005099803-2013-01446
- Event Type
- Injury
- Date Received
- March 6, 2013
- Report Date
- February 15, 2013
- 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
Description of Event or Problem · 1
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES IMPLANTED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2013-01445 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT AND A SOLYX SINGLE INCISION SLING SYSTEM WERE IMPLANTED INTO THE PATIENT ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96265 | SOLYX SIS SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT |