FDA Adverse Event
Injury
Summary report: N
SILASTIC(R) MAMMARY IMPLANT
MDR report key: 52282
·
Received November 25, 1996
Report
- Report Number
- 1816403-1996-00322
- Event Type
- Injury
- Date Received
- November 25, 1996
- Report Date
- October 31, 1996
- Manufacturer
- DOW CORNING CORP
- Product Code
- FTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
ATTORNEY ALLEGES FOLLOWING IMPLANTATION, PLAINTIFF DEVELOPED INJURIES WHICH INCLUDED A DISEASE OR DISORDER. PARTICULARS OF THE INJURIES INCLUDE: CAPSULAR CONTRACTURE, BREAST PAIN, MASTITIS, BREAST LUMPS, SILICONE LEAKAGE, DELAYED DETECTION OF BREAST CANCER, AUTOIMMUNE DISEASE IN THE FORM OF IMMUNE REACTION TO SILICONE, INTERFACE WITH IMMUNE SYSTEM AND DEVELOPMENT OF SILICONE SYNDROME, JOINT PAIN, SKIN RASHES, CHEST PAIN, SHORTNESS OF BREATH, FATIGUE AND SLEEP DISTURBANCES, COSMETIC DAMAGE, ANXIETY, NERVOUSNESS AND DEPRESSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC(R) MAMMARY IMPLANT Implant | MAMMARY IMPLANT, GEL-FILLED | FTR | DOW CORNING CORP | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other| R |