FDA Adverse Event
Summary report: N
HEYER-SCHULTE MAMMARY PROSTHESIS
MDR report key: 13438
·
Received May 23, 1994
Report
- Report Number
- MW1002153
- Date Received
- May 23, 1994
- Date of Event
- December 27, 1977
- Report Date
- May 12, 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 CHEST PAIN, WEAKNESS IN BOTH ARMS, THORACIC OUTLET SYNDROME, FIBROMYALGIA, FATIGUE, SLEEP DISORDERS, DEPRESSION, AND RAYNAUD'S SYNDROME. (SAME RPTR REFERRED IN 1002152, 1002154 AND 1002155.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEYER-SCHULTE MAMMARY PROSTHESIS Implant | FTR | V. MUELLER DIV. BAXTER HEALTHCARE CORP. | 142823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |