FDA Adverse Event
Summary report: N
HEYER-SCHULTE MAMMARY PROSTHESIS
MDR report key: 13506
·
Received May 24, 1994
Report
- Report Number
- MW1002203
- Date Received
- May 24, 1994
- Date of Event
- May 28, 1985
- Report Date
- May 13, 1994
- Manufacturer
- MENTOR CORP.
- Product Code
- FWM
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
RPTR COMPLAINS OF ACHES AND PAINS, DRY MOUTH, PAINFUL BREASTS, ITCHING, SWELLING OF ANKLES AND FEET, FATIGUE, HAIR LOSS, RASHES, FIBROSIS, AND HIGH BLOOD PRESSURE. (SAME RPTR REFERRED TO IN 1002202.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEYER-SCHULTE MAMMARY PROSTHESIS Implant | FWM | MENTOR CORP. | 5005, 2265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * * |