FDA Adverse Event
Injury
Summary report: N
ADVANTAGE SYSTEM
MDR report key: 3203293
·
Received July 2, 2013
Report
- Report Number
- 3005099803-2013-05514
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- June 11, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
DR (B)(6) WAS REPORTED TO BE THE PHYSICIAN; HOWEVER, DR (B)(6) INDICATED THAT SHE DOES NOT PERFORM THIS TYPE OF PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300906 | ADVANTAGE SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |