FDA Adverse Event
Summary report: N
HEYER-SCHULTE MAMMARY PROSTHESIS
MDR report key: 13342
·
Received May 18, 1994
Report
- Report Number
- MW1002068
- Date Received
- May 18, 1994
- Date of Event
- December 4, 1978
- Report Date
- May 5, 1994
- Manufacturer
- V. MUELLER DIV. BAXTER HEALTHCARE CORP.
- Product Code
- FTR
- 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, HARD AND PAINFUL BREASTS, ITCHING, REDNESS AND SWELLING OF SKIN, SWELLING OF JOINTS, HANDS AND FEET, FATIGUE, HAIR LOSS, RASHES, AND SHORTNESS OF BREATH. (SEE ALSO 1002069.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEYER-SCHULTE MAMMARY PROSTHESIS Implant | FTR | V. MUELLER DIV. BAXTER HEALTHCARE CORP. | 169503 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |