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 * *