FDA Adverse Event
Other
Summary report: N
BREAST IMPLANT
MDR report key: 11197
·
Received February 2, 1994
Report
- Report Number
- MW1000568
- Event Type
- Other
- Date Received
- February 2, 1994
- Manufacturer
- UNKNOWN
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IMPLANT PLACED FOR AUGMENTATION 5/28/74. IMPLANT RUPTURED PRIOR TO 1986 (APPROX) AS CONFIRMED BY MAMMOGRAM. RPTR STATES THIS IS CAUSING HEALTH PROBLEMS. COMPLAINTS INCLUDE ARTHRITIS, GALL BLADDER DISEASE, IRRITABLE BOWEL SYNDROME, HAIR LOSS, MEMORY LOSS, PSORIASIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREAST IMPLANT | FTR | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |