FDA Adverse Event
Injury
Summary report: N
MAMMARY PROSTHESIS
MDR report key: 255510
·
Received December 21, 1999
Report
- Report Number
- 255510
- Event Type
- Injury
- Date Received
- December 21, 1999
- Date of Event
- November 16, 1999
- Report Date
- November 16, 1999
- Manufacturer
- HEYER-SCHULTE CORP
- Product Code
- FTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
LEFT BREAST IMPLANT DEFLATION RESULTING IN BREAST ASSYMETRY FOLLOWING IMPLANTATION NOV., 1983.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMARY PROSTHESIS Implant | MAMMARY PROSTHESIS | FTR | HEYER-SCHULTE CORP | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization |