FDA Adverse Event
Injury
Summary report: N
LYNX SYSTEM
MDR report key: 1565973
·
Received December 22, 2009
Report
- Report Number
- 3005099803-2009-06200
- Event Type
- Injury
- Date Received
- December 22, 2009
- Report Date
- November 30, 2009
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN LYNX SUPRAPUBIC SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE IN 2004. ACCORDING TO THE COMPLAINANT, THE PT PRESENTED WITH EROSION. SEVERAL ATTEMPTS AT FOLLOW UP HAVE BEEN UNSUCCESSFUL.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN LYNX SUPRAPUBIC SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE ON (B)(6) 2004. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH EROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LYNX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068503000 | 0ML4091303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |