FDA Adverse Event
Malfunction
Summary report: N
OBTRYX MESH SLING SYSTEM
MDR report key: 1191233
·
Received September 25, 2008
Report
- Report Number
- 3005099803-2008-04867
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- May 6, 2008
- Report Date
- August 27, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL VISUAL INSPECTION OF RETURNED DEVICE REVEALED THE PLASTIC SHEATH, JUST ABOVE THE BLUE CONE DILATOR WAS TORN AND SEPARATED FROM THE IMPLANT. NO PART WAS MISSING. THE CONE AND ASSOCIATION LOOP REMAINED ON THE TROCAR AND THE REMAINDER OF THE IMPLANT WAS REMOVED IN ONE PIECE. ANALYSIS OF THE DEVICE IS NOT COMPLETE AND WILL BE FILED IN A SUPPLEMENT REPORT.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A PROCEDURE, TO PLACE THE OBTRYX MESH SLING, THE DEVICE FELL APART DURING INSERTION AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTRYX MESH SLING SYSTEM | FTL | BOSTON SCIENTIFIC CORPORATION | M0068504001 | 0ML7091403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |