FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 1900926
·
Received November 17, 2010
Report
- Report Number
- 3005099803-2010-04715
- Event Type
- Injury
- Date Received
- November 17, 2010
- Report Date
- October 25, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE LOT NUMBER WAS REPORTED TO BE 0XL6110922.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT ON (B)(4), 2010 PROVIDING DEVICE, PATIENT, AND PROCEDURAL INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM WAS USED DURING A SLING PROCEDURE TO TREAT STRESS URINARY INCONTINENCE PERFORMED ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH EROSION AND "SERIOUS BODILY INJURIES".
Description of Event or Problem · 1
THE PROCEDURE WAS COMPLETED PER NORMAL PROTOCOL WITHOUT COMPLICATIONS. IT WAS NOTED, IMMEDIATELY POST PROCEDURE, THAT THE PATIENT TOLERATED THE PROCEDURE WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068504000 | 0ML6110912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |