FDA Adverse Event
Injury
Summary report: N
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
MDR report key: 1882169
·
Received October 25, 2010
Report
- Report Number
- 2125050-2010-00012
- Event Type
- Injury
- Date Received
- October 25, 2010
- Date of Event
- September 27, 2010
- Report Date
- September 27, 2010
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K082640
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS DISCARDED SO WAS NOT AVAILABLE FOR RETURN; THUS, NO EVALUATION COULD BE PERFORMED. COLOPLAST DID RECEIVE A PHOTOGRAPH OF THE DEVICE AND CONFIRMS THE REPORT OF BROKEN ARMS. DEVICE DISCARDED - NOT RETURNED.
Description of Event or Problem · 1
(B)(4). ARMS BROKE AFTER MINIMAL TENSION APPLIED. ANOTHER SLING WAS USED, AND THE ARM BROKE ON IT AS WELL. PRODUCT DISCARDED & NOT AVAILABLE TO RETURN FOR EVALUATION. SURGERY WAS ABORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | SURGICAL MESH | FTL | COLOPLAST A/S | 5002011400 | 2306414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |