FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 3200667
·
Received July 1, 2013
Report
- Report Number
- 3005099803-2013-05628
- Event Type
- Injury
- Date Received
- July 1, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 STATED THAT THE PATIENT EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS, AND DISFIGUREMENT.
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) 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. 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 |
|---|---|---|---|---|---|---|---|
| 299143 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068505000 | 0ML8080701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | XENFORM SOFT TISSUE REPAIR MATRIX 4CM X 7CM| XENFORM SOFT TISSUE REPAIR MATRIX 8CM X 12CM |