FDA Adverse Event
Injury
Summary report: N
LYNX SYSTEM
MDR report key: 1904559
·
Received November 22, 2010
Report
- Report Number
- 3005099803-2010-04908
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 3, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM WAS USED DURING A VAGINAL SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT'S RIGHT SIDE OF THE BLADDER WAS PERFORATED. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT, BUT THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT WAS DISCHARGED HOME WITH A FOLEY CATHETER IN PLACE TO ALLOW THE BLADDER TO HEAL. THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LYNX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068503001 | 1ML0062304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |