FDA Adverse Event Summary report: N

GEL-FILL MAMMARY IMPLANT, 260 CC

MDR report key: 16540 · Received October 3, 1994

Report

Report Number
MW1003566
Date Received
October 3, 1994
Date of Event
August 5, 1976
Report Date
September 25, 1994
Manufacturer
MCGHAN MEDICAL CORP.
Product Code
FTR
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

RPTR COMPLAINED OF SEVERE JOINT PAIN - ELBOWS, KNEES, SHOULDERS, FINGERS, AND TOES, PERIODIC PAIN WHEN ARMS ARE TOUCHED AND CONTINUAL PAIN WHEN UPPER SIDES OR BACK ARE TOUCHED, EXTREME PAIN AND FATIGUE OF HANDS AND FINGERS - RPTR DROPS THINGS VERY OFTEN. IF SHE BUMPS HER HANDS, THE PAIN IS DEEP AND EXCRUCIATING. VAGUE NUMBNESS AND TINGLING FROM KNEES INTO FEET AND FROM SHOULDERS INTO HANDS - NOT CONTINUAL BUT SEVERAL TIMES A WEEK. ARMS TIRE EASILY THEN PAIN BEGINS WHEN SHOPPING, WASHING, CURLING HAIR, AND DRIVING, LEG AND BUTTOCK MUSCLES ACHE, EXTREME FATIGUE, VARIOUS SENSATIONS ANYWHERE ON HER BODY, AS THOUGH SOMETHING IS CRAWLING ON HER. TOUCHY, ENLARGED GLAND UNDER RIGHT EAR, GLANDS IN GROIN OFTEN ENLARGED AND TOUCHY. DIFFICULT TO KEEP FROM "LEAKING" URINE. URINE HAS STRONG SMELL AND IS OFTEN CLOUDY. RASHES ON SCALP, FACE, NECK, CHEST, AND BACK. EXTREME ITCHING OF ALL AREAS AGGRAVATED BY HEAT. SMALL HARD, WHITE AND SCALY PATCHES APPEARING ON LEGS. PERIODIC TROUBLE SWALLOWING. SHE TENDS TO "BLACKOUT" ONCE IN A WHILE, NOT UNCONSCIOUSNESS BUT MORE LIKE VISION GOES DARK AND SHE IS MOMENTARILY DISORIENTED, THEN THE LEFT SIDE OF HER FACE IS USUALLY NUMB. BURNING, ITCHY EYES, VERY SENSITIVE TO SUNLIGHT. SHARP, SHOOTING PAIN AND BURNING IN BOTH BREASTS. PAIN WHEN BREASTS ARE TOUCHED, NO SEXUAL DESIRE, TENDENCY TO KEEP COLDS, FLU, ETC, BREATHING DIFFICULTY, NO ABDOMINAL REFLEX AND CHANGE IN RIGHT BREAST, SMALLER AND SOFTER AND "LUMPY." LEFT BREAST VERY FIRM. MAMMOGRAM IN 1987 SHOWS CALCIFICATION; SMALL AMOUNT GLANDULAR TISSUE. (*). (ALSO SEE #1003565).THIS INFO WAS SUBMITTED AS FOLLOW-UP 10/31/94: DIAGNOSED 10/7/94 WITH ATYPICAL CONNECTIVE TISSUE DISEASE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GEL-FILL MAMMARY IMPLANT, 260 CC FTR MCGHAN MEDICAL CORP.

Patients

Seq Age Sex Outcome Treatment
1 *