FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 2993484
·
Received March 7, 2013
Report
- Report Number
- 3005099803-2013-01222
- Event Type
- Injury
- Date Received
- March 7, 2013
- Report Date
- February 15, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NOTE: THIS MFR REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2013-01221 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) 2011.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS.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 |
|---|---|---|---|---|---|---|---|
| 97010 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM |