FDA Adverse Event
Summary report: N
GEL-FILLED MAMMARY IMPLANT LP, 240 CC
MDR report key: 17484
·
Received November 2, 1994
Report
- Report Number
- MW1003950
- Date Received
- November 2, 1994
- Report Date
- November 2, 1994
- Manufacturer
- DOW CORNING CORP.
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
FLU AND ARTHRITIS SYMPTOMS, SEVERE HYPERTENSION, JOINT SWELLING, PAIN AND STIFFNESS, MUSCLE FATIGUE, BREAST TENDERNESS, FATIGUE, SWOLLEN GLANDS, COLDNESS/PAIN OF EXTREMITIES, FIRST IMPLANTS TOO SMALL, NOW IMPLANTS TOO HEAVY, VISIBLE IMPLANT WRINKLES, COLD ALL OF TIME, LONG HEALING PERIODS, ACHES AND PAINS, SHORTNESS OF BREATH, EMOTIONAL PROBLEMS BECAUSE OF APPEARANCE, MEMORY PROBLEMS, ARTHRITIC COMPLAINTS IN SHOULDERS AND ANKLES, RAYNAUD'S FEVER, CHILLS, PARESTHESIAS, HEADACHES. ALSO SEE 1003951, 1003952, 1003953, 1003954.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEL-FILLED MAMMARY IMPLANT LP, 240 CC Implant | FTR | DOW CORNING CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |