FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 2900298
·
Received January 7, 2013
Report
- Report Number
- 3005099803-2012-06419
- Event Type
- Injury
- Date Received
- January 7, 2013
- Report Date
- December 13, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT AGE PROVIDED IS THE AGE OF THE PATIENT AT THE TIME THE DEVICE WAS IMPLANTED. ALTHOUGH THE EXACT IMPLANT DATE IS UNKNOWN, IT WAS REPORTED TO BE IN 2008.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED INTO THE PATIENT IN 2008 AFTER CHILDBIRTH. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PHYSICAL PAIN AND SUFFERING AND CLAIMS THAT SHE MAY NOT BE ABLE TO HAVE A SECOND CHILD, AND THAT SHE HAS INTIMACY ISSUES AND CONSTANT PAIN. THE DEVICE HAD TO BE REMOVED IN 2010. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6387 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |