FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 3200710
·
Received July 1, 2013
Report
- Report Number
- 3005099803-2013-05443
- Event Type
- Injury
- Date Received
- July 1, 2013
- Report Date
- June 11, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- OTN
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Additional Manufacturer Narrative · 1
EXACT IMPLANT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED TO BE IN (B)(6) 2006.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED INTO THE PATIENT IN (B)(6) 2006. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.
Description of Event or Problem · 1
AS REPORTED BY THE PATIENT¿S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. 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 |
|---|---|---|---|---|---|---|---|
| 297854 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | BOSTON SCIENTIFIC - MARLBOROUGH | UNK676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |