FDA Adverse Event
Injury
Summary report: N
ADVANTAGE SYSTEM
MDR report key: 2853290
·
Received November 30, 2012
Report
- Report Number
- 3005099803-2012-05711
- Event Type
- Injury
- Date Received
- November 30, 2012
- Report Date
- November 6, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2004. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN, THE PATIENT RETURNED FOR A FOLLOW-UP APPOINTMENT ON (B)(6) 2006 (SPECIFICS UNKNOWN). THE PHYSICIAN DID NOT NOTE OF THE PATIENT HAVING ANY COMPLICATIONS POST-IMPLANTATION. REPORTEDLY, THE PATIENT HAS NOT RETURNED TO SEE ANY PHYSICIAN SINCE (B)(6) 2006. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTAGE SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |