FDA Adverse Event
Injury
Summary report: N
ADVANTAGE SYSTEM
MDR report key: 2742574
·
Received September 13, 2012
Report
- Report Number
- 3005099803-2012-04143
- Event Type
- Injury
- Date Received
- September 13, 2012
- Report Date
- August 29, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED LOT NUMBER 850200 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 AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN, DYSPAREUNIA AND ADDITIONAL PROCEDURE/SURGERY TO REMOVE THE RIGHT ARM OF THE SLING. ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND REPORTEDLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTAGE SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068502000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |