FDA Adverse Event
Injury
Summary report: N
ALIGN TO URETHRAL SUPPORT SYSTEM
MDR report key: 3062828
·
Received April 12, 2013
Report
- Report Number
- 1018233-2013-01293
- Event Type
- Injury
- Date Received
- April 12, 2013
- Report Date
- November 5, 2015
- Manufacturer
- C.R. BARD, INC. (COVINGTON)
- Product Code
- FTL
- PMA / PMN Number
- K070073
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. ONCE COMPLETED, AN MDR SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01294.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157509 | ALIGN TO URETHRAL SUPPORT SYSTEM | Mesh, surgical, polymeric | FTL | C.R. BARD, INC. (COVINGTON) | NA | CVRJ0022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention | AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM| AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM |