FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 1974409
·
Received January 31, 2011
Report
- Report Number
- 3005099803-2011-00252
- Event Type
- Injury
- Date Received
- January 31, 2011
- Report Date
- January 11, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE HOSPITAL WHERE THE PROCEDURE TOOK PLACE IS UNKNOWN, HOWEVER, THE PATIENT REPORTEDLY LIVES IN (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE INVOLVING AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM TO TREAT THE PATIENT'S STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. ACCORDING TO THE COMPLAINANT, THE PATIENT SUFFERED SERIOUS BODILY INJURIES, INCLUDING EROSION OF INTERNAL BODILY TISSUES. THE EXACT NATURE OF ALL BODILY INJURIES IS UNKNOWN. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE AND THE PATIENT'S CURRENT CONDITION ARE UNKNOWN AND REPORTEDLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |