FDA Adverse Event
Injury
Summary report: N
ANATOMICAL DOUBLE CHAMBER TISSUE EXPANDER
MDR report key: 2960269
·
Received February 8, 2013
Report
- Report Number
- 1651189-2013-00004
- Event Type
- Injury
- Date Received
- February 8, 2013
- Date of Event
- November 29, 2012
- Report Date
- February 1, 2013
- Manufacturer
- SIENTRA, INC
- Product Code
- LCJ
- PMA / PMN Number
- K981852
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RIGHT-SIDE DEVICE REMOVED AN PART OF BILATERAL REPLACEMENT DUE TO REPORTED LEAKAGE OF LEFT-SIDE DEVICE. NO REPORTED DEFECT OF THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53564 | ANATOMICAL DOUBLE CHAMBER TISSUE EXPANDER | LCJ | SIENTRA, INC | 20799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |