FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 2841894
·
Received November 21, 2012
Report
- Report Number
- 3005099803-2012-05523
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- November 2, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT DATE IS UNKNOWN; HOWEVER THE PATIENT WAS REPORTED TO BE (B)(6) AT IMPLANTATION.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN.
Description of Event or Problem · 1
ACCORDING TO THE PHYSICIAN, POST PROCEDURE ON (B)(6) 2011, THE PATIENT HAD A CYSTOSCOPY EXAM AND THE RESULTS WERE NORMAL. THE PATIENT WAS LAST SEEN IN (B)(6) 2012. THE PATIENT DID NOT PRESENT WITH ANY COMPLICATIONS AND WAS NOT PRESCRIBED ANY MEDICATION. ALL OTHER INFORMATION IS UNKNOWN AND 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 |