FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 2955622
·
Received February 11, 2013
Report
- Report Number
- 3005099803-2013-00739
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- January 22, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2013-00740 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED INFECTION, INFLAMMATION, MESH EROSION, PELVIC PAIN, PAIN WITH URINATION, DYSPAREUNIA, VAGINAL PAIN, MIGRATION, BLEEDING AND DISCHARGE. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58176 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068505001 | 0ML9111802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | UPHOLD VAGINAL SUPPORT SYSTEM |