FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 3232822
·
Received July 18, 2013
Report
- Report Number
- 3005099803-2013-07056
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- June 21, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED LOT # OML7121303 COULD NOT BE MATCHED TO THE UPN PROVIDED.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX CURVED SINGE SYSTEM DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 335077 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068504000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |