FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 3013276
·
Received March 20, 2013
Report
- Report Number
- 3005099803-2013-01476
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- February 27, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN'S OFFICE, IT WAS REPORTED THAT THE PATIENT CONTACTED THE DOCTOR WITH SOME ABDOMINAL PAIN IN (B)(6) 2012. HOWEVER, A CAT SCAN WAS PERFORMED AND IT WAS DETERMINED THAT THE PAIN WAS DUE TO KIDNEY STONES. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116627 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |