FDA Adverse Event
Injury
Summary report: N
LYNX SYSTEM
MDR report key: 3221339
·
Received July 11, 2013
Report
- Report Number
- 3005099803-2013-05966
- Event Type
- Injury
- Date Received
- July 11, 2013
- Report Date
- June 17, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT LISTED TWO FACILITIES ASSOCIATED WITH THIS COMPLAINT, (B)(6). IT IS UNKNOWN WHICH FACILITY THE DEVICE WAS IMPLANTED AT.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC 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 |
|---|---|---|---|---|---|---|---|
| 319862 | LYNX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |