FDA Adverse Event
Injury
Summary report: N
ADVANTAGE SYSTEM
MDR report key: 3052982
·
Received April 11, 2013
Report
- Report Number
- 3005099803-2013-02140
- Event Type
- Injury
- Date Received
- April 11, 2013
- Report Date
- March 15, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT LISTED TWO FACILITIES ASSOCIATED WITH THIS COMPLAINT, UNIVERSITY MEDICAL CENTER AND CANDLER HOSPITAL, SAVANNAH GA. IT IS UNKNOWN WHICH FACILITY THE DEVICE WAS IMPLANTED AT. THE COMPLAINANT ALSO LISTED THE FOLLOWING PHYSICIANS ASSOCIATED WITH THIS COMPLAINT: (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. 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 |
|---|---|---|---|---|---|---|---|
| 154962 | ADVANTAGE SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |