FDA Adverse Event
Malfunction
Summary report: N
ANATOMICAL DOUBLE CHAMBER TISSUE EXPANDER
MDR report key: 1191234
·
Received September 25, 2008
Report
- Report Number
- 1651189-2008-00009
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- July 17, 2008
- Report Date
- September 4, 2008
- Manufacturer
- SIENTRA, INC
- Product Code
- LCJ
- PMA / PMN Number
- K981852
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED ON THE PT'S LEFT BREAST IN 2008. ON HER WEEKLY EXPANSION APPOINTMENT, TWO AND A HALF MONTHS LATER, HER DR NOTICED THAT THE EXPANDER DID NOT SEEM TO HAVE RETAINED THE FULL VOLUME OF SALINE THAT HAD BEEN INJECTED INTO IT ON THE PREVIOUS APPOINTMENTS. THE DR DECIDED TO ADD 50CC AND SEE WHETHER THE EXPANDER RETAINED IT. THE PT NOTICED THAT IT SEEMED TO BE DEFLATING AND BECAUSE OF THIS, SHE WAS SCHEDULED FOR SURGERY. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER TISSUE EXPANDER (FROM A DIFFERENT MFR) APPROX ONE WEEK LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANATOMICAL DOUBLE CHAMBER TISSUE EXPANDER | LCJ | SIENTRA, INC | 20779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |