FDA Adverse Event
Injury
Summary report: N
VIRTUE MALE SLING SYSTEM
MDR report key: 3242634
·
Received July 23, 2013
Report
- Report Number
- 2125050-2013-00087
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- June 18, 2013
- Report Date
- July 23, 2013
- Manufacturer
- COLOPLAST A/S
- Product Code
- OTM
- PMA / PMN Number
- K111881
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT IMPLANTED WITH VIRTUE SLING ON (B)(6) /2011. PATIENT REPORTED PERINEAL PAIN ON (B)(6) 2012 AND WAS TREATED FOR PAIN MANAGEMENT. SLING WAS SUBSEQUENTLY EXPLANTED (B)(6) 2013 WITH NO COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343820 | VIRTUE MALE SLING SYSTEM | SURGICAL MESH | OTM | COLOPLAST A/S | 5002022400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |