FDA Adverse Event
Injury
Summary report: N
ACX DOUBLE CHAMBER TISSUE EXPANDER
MDR report key: 3133381
·
Received May 24, 2013
Report
- Report Number
- 1651189-2013-00009
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- April 8, 2013
- Report Date
- May 24, 2013
- Manufacturer
- SIENTRA, INC
- Product Code
- LCJ
- PMA / PMN Number
- K981852
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LEFT-SIDE BREAST TISSUE EXPANDER REPORTED DEFLATION. EXPLANTATION AND REPLACEMENT WITH IDENTICAL BREAST TISSUE EXPANDER FOR CONTINUATION OF TREATMENT (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231355 | ACX DOUBLE CHAMBER TISSUE EXPANDER | LCJ | SIENTRA, INC | 20799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |