FDA Adverse Event
Injury
Summary report: N
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
MDR report key: 1571546
·
Received January 7, 2010
Report
- Report Number
- 2125050-2010-00001
- Event Type
- Injury
- Date Received
- January 7, 2010
- Date of Event
- November 11, 2009
- Report Date
- December 11, 2009
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- FTL
- PMA / PMN Number
- K082640
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INITIALLY-IMPLANTED DEVICE WAS NOT RETURNED, SO NO EVALUATION WAS PERFORMED. THE DEVICE USED FOR REVISION REMAINS IMPLANTED IN THE PATIENT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST, A PATIENT WENT IN FOR A PLANNED REVISION OF THE INITIAL SLING. DURING SLING REVISION, WHEN APPLYING TENSION TO THE RIGHT PREPUBIC ARM, IT SNAPPED. THE TECHNIQUE USED TO IMPLANT THE NEW SLING WAS DIFFERENT FROM THE PROTOCOL-DIRECTED TECHNIQUE. THE SLING WAS THEN FULLY EXPLANTED, AND A NEW VIRTUE SLING WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | SURGICAL MESH | FTL | COLOPLAST MANUFACTURING US, LLC | 5002001400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |