FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 1940392
·
Received December 29, 2010
Report
- Report Number
- 3005099803-2010-05221
- Event Type
- Injury
- Date Received
- December 29, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 7, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO SINGLE SYSTEM DEVICE WAS USED DURING A SLING PLACEMENT PROCEDURE. THE PATIENT WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, THE OBTRYX DELIVERY DEVICE NEEDLE PERFORATED THE VAGINA ON THE INITIAL PASS THROUGH THE PATIENT. THE NEEDLE WAS REMOVED FROM THE PATIENT AND A SUTURE REPAIR WAS PERFORMED TO TREAT THE PERFORATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT'S CONDITION POST PROCEDURE WAS REPORTED TO BE "FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068505000 | 0ML8102801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |