FDA Adverse Event
Summary report: N
SILASTIC GEL-FILLED MAMMARY IMPLANT
MDR report key: 16482
·
Received September 29, 1994
Report
- Report Number
- MW1003533
- Date Received
- September 29, 1994
- Date of Event
- May 11, 1984
- Report Date
- September 19, 1994
- Manufacturer
- DOW CORNING CORP.
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
EDEMA/SWELLING, IRREGULAR BREAST SHAPE, UTERINE, VAGINAL AND MENSTRUAL PROBLEMS, BLOOD VESSEL (VASCULAR) PROBLEMS, CALCIUM DEPOSITS, BLEEDING, HEMATOMA, AND INFECTION, LOSS OF NIPPLE/BREAST SENSATION, SENSITIVITY TO HEAT AND COLD, SUN SENSITIVITY, CHRONIC FATIGUE, JOINT PAIN, STIFFNESS, SWELLING, WEAKNESS AND PAIN TO EXTREMITIES, MUSCLE PAIN, SKIN AND TISSUE DISORDERS, LOW GRADE FEVER, SWEATS, CHILLS, IRRITABLE BOWEL SYNDROME, VISION PROBLEMS, CHEST PAINS, ANXIETY, DEPRESSION AND INFERTILITY. (ALSO SEE 1003534.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC GEL-FILLED MAMMARY IMPLANT Implant | SILASTIC GEL IMPLANT | FTR | DOW CORNING CORP. | HH033488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |