FDA Adverse Event
Injury
Summary report: N
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
MDR report key: 1595755
·
Received February 8, 2010
Report
- Report Number
- 2125050-2010-00002
- Event Type
- Injury
- Date Received
- February 8, 2010
- Date of Event
- December 10, 2009
- Report Date
- January 12, 2010
- 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
ONE PORTION OF THE MALE SLING WAS RETURNED FOR EVALUATION. BECAUSE COLOPLAST'S EXAMINATION OF THE RETURNED SLING MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF DISSATISFACTION / LEAKAGE, A MICROSCOPIC EXAMINATION WAS NOT PERFORMED. BASED ON THE INFORMATION PROVIDED, COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION.
Description of Event or Problem · 1
(B) (6). AS REPORTED TO COLOPLAST, A PATIENT EXPRESSED DISSATISFACTION WITH THE SLING, WHICH WAS THEN EXPLANTED. THE DISSATISFACTION WAS NOT BEING AS DRY AS HE WANTED TO BE (LEAKAGE).
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 | 5002011400 | 1899450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |