FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 2914857
·
Received January 15, 2013
Report
- Report Number
- 3005099803-2013-00157
- Event Type
- Injury
- Date Received
- January 15, 2013
- Report Date
- December 17, 2012
- 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 REPORT PERTAINS TO ONE OF TWO DEVICES IMPLANTED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2013-00156 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23379 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | UPHOLD VAGINAL SUPPORT SYSTEM |