FDA Adverse Event
Injury
Summary report: N
MAMMARY IMPLANT
MDR report key: 26714
·
Received October 10, 1995
Report
- Report Number
- MW1007281
- Event Type
- Injury
- Date Received
- October 10, 1995
- Date of Event
- November 2, 1981
- Report Date
- September 17, 1995
- Manufacturer
- DOW CORNING, PNR
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Voluntary report
Narratives
Description of Event or Problem · 1
BREAST IMPLANT CAUSED SEVERAL MEDICAL PROBLEMS INCLUDING LUPUS, SWOLLEN LIMBS, DIZZINESS, ETC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMARY IMPLANT Implant | BREAST IMPLANT | FTR | DOW CORNING, PNR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Life Threatening| S |