FDA Adverse Event
Summary report: N
MAMMARY PROSTHESIS
MDR report key: 13490
·
Received May 24, 1994
Report
- Report Number
- MW1002189
- Date Received
- May 24, 1994
- Date of Event
- August 3, 1993
- Report Date
- May 13, 1994
- Manufacturer
- MCGHAN MEDICAL CORP.
- Product Code
- FWM
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
RPTR COMPLAINS OF RASHES, SCALY SKIN, BURNING PAIN IN CHEST, DRY EYES AND VAGINA, HANDS TURN WHITE IN COLD, JOINT SWELLING AND TENDERNESS, ENLARGED LYMPH NODES, MUSCLE ACHES, PAINS AND WEAKNESS, LOSS OF MEMORY AND SENSATION, HAIR LOSS, BLADDER AND COLON PROBLEMS, CHRONIC FATIGUE, LOW GRADE FEVER, AND EYE PROBLEMS. (SAME RPTR REFERRED TO IN 1002190.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMARY PROSTHESIS Implant | FWM | MCGHAN MEDICAL CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * * |