FDA Adverse Event
Injury
Summary report: N
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
MDR report key: 1695122
·
Received May 20, 2010
Report
- Report Number
- 2125050-2010-00007
- Event Type
- Injury
- Date Received
- May 20, 2010
- Date of Event
- February 8, 2010
- Report Date
- April 22, 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
THE DEVICE REMAINS IMPLANTED IN THE PATIENT, SO NO EVALUATION WAS PERFORMED. BECAUSE THE DEVICE REMAINS IMPLANTED AND BECAUSE COLOPLAST'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PAIN, COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATION OF PAIN AS THE REASON FOR THE MEDICAL INTERVENTION. DEVICE STILL IMPLANTED - NOT RETURNED.
Description of Event or Problem · 1
(B) (6). AS REPORTED TO COLOPLAST, A PATIENT EXPERIENCED MILD SCROTAL PAIN AT 3 MONTHS AFTER IMPLANT AND IS TREATED WITH PHYSICAL THERAPY. THE PAIN IS UNRESOLVED. THE DEVICE REMAINS IMPLANTED TO DATE.
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 | 1908488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |