FDA Adverse Event
Injury
Summary report: N
ADVANTAGE SYSTEM
MDR report key: 1754427
·
Received July 13, 2010
Report
- Report Number
- 3005099803-2010-00292
- Event Type
- Injury
- Date Received
- July 13, 2010
- Date of Event
- August 4, 2008
- Report Date
- August 4, 2008
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4)(B) (6).
Additional Manufacturer Narrative · 1
PRODUCT UNAVAILABLE FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UNDER GENERAL ANESTHESIA, THE PATIENT EXPERIENCED MORE THAN USUAL BLOOD LOSS. THE PATIENT'S PAIN WAS REPORTED AS VAS 55/100.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UNDER GENERAL ANESTHESIA, THE PATIENT EXPERIENCED MORE THAN USUAL BLOOD LOSS. THE PATIENT'S PAIN WAS REPORTED AS VAS 55/100.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTAGE SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK13 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other | POSTERIOR REPAIR |