FDA Adverse Event
Summary report: N
HEYER-SCHULTE SALINE-FILLED MAMMARY PROSTHESIS, 275 CC
MDR report key: 17748
·
Received November 15, 1994
Report
- Report Number
- MW1004032
- Date Received
- November 15, 1994
- Report Date
- November 8, 1994
- Manufacturer
- V. MUELLER DIV. BAXTER HEALTHCARE CORP.
- Product Code
- FWM
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON 5/30/79, RPTR HAD REMOVAL OF RIGHT IMPLANT. PLACEMENT OF ANOTHER CO'S PROSTHESIS. RPTR HAD IMPLANT TO REPLACE. ON 8/20/80, SHE HAD ANOTHER CO'S IMPLANT. ON 10/15/80, SHE HAD RIGHT AUGMENTATION DONE UNDER LOCAL USING UNKNOWN BRAND IMPLANTS. SHE ALSO COMPLAINS OF BREAST DRAINAGE AND SWELLING, ALLERGIC DERMATITIS, FATIGUE, RHEUMATOID ARTHRITIS, SYMMETRICAL POLYARTHRITIS, SYNOVIAL SWELLING AND TENDER JOINTS, AARTHRALGIAS AND MYALGIAS, IMPLANT LEAKAGE, MUSCLE FATIGUE, GENERAL ACHING AND STIFFNESS. (ALSO SEE 1004031.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEYER-SCHULTE SALINE-FILLED MAMMARY PROSTHESIS, 275 CC | BREAST IMPLANT | FWM | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |