FDA Adverse Event
Injury
Summary report: N
SILASTIC TISSUE EXP SCV 200CC
MDR report key: 214624
·
Received March 15, 1999
Report
- Report Number
- 1816403-1999-00102
- Event Type
- Injury
- Date Received
- March 15, 1999
- Manufacturer
- DOW CORNING CORP.
- Product Code
- LCJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DESCRIPTION OF COMPLAINT STATES TISSUE EXPANDER WAS REMOVED AS IT LEAKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC TISSUE EXP SCV 200CC Implant | TISSUE EXPANDER | LCJ | DOW CORNING CORP. | P2000200 | HH015019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |