FDA Adverse Event Summary report: N

REPLICON NATURAL Y POLYURETHANE COATED BREAST IMPLANT

MDR report key: 13989 · Received June 14, 1994

Report

Report Number
MW1002462
Date Received
June 14, 1994
Report Date
June 9, 1994
Manufacturer
MEDICAL ENGINEERING CORP.
Product Code
FTR
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON 3/24/88, RPTR HAD ANOTHER CO'S IMPLANTS REMOVED WITH A CAPSULECTOMY. THE IMPLANTS WERE REPLACED WITH THIS CO'S IMPLANTS. ON 5/1/91, RIGHT BREAST LUMP WAS REMOVED. THERE WAS NO PATHOLOGY REPORT, APPEARED BENIGN. OTHER PROBLEMS NOTED INCLUDE: FIBROCYSTIC DISEASE, BREAST PAIN, ARM PAIN, NERVOUSNESS, BREAST/CHEST DEFORMITIES, BREAST LUMPS, RUPTURE, BREAST REDNESS/HEAT, STICKY THROAT, WHEEZING, SHORTNESS OF BREATH, RASH-BUTTERFLY AREA WHICH IS EFFECTED BY SUN, SCALING FEET, INCREASED TEMPERATURE, PAIN BEHIND BREAST RADIATING TO BACK, MUSCLE PAIN, NECK MASS, HIP BONE GRAFTS, HIP REPLACEMENT, GALL BLADDER SURGERY, CARPAL TUNNEL, UNDERACTIVE THYROID, POSSIBLE LUPUS, DEGENERATIVE ARTHRITIS, BENIGN TUMORS, ARTHRITIS SYMPTOMS, JOINT SWELLING, PAIN, AND STIFFNESS IN ELBOWS, SHOULDERS, SHOULDER BLADES, NECK AND FEET, MUSCLE FATIGUE, SWELLING FEET AND HANDS, THICK SKIN OVER BREAST AREA, BREAST TENDERNESS AND BURNING, EXTREME FATIGUE, MEMORY PROBLEMS, DEPRESSION, GENERAL ACHING/STIFFNESS, SWOLLEN GLANDS ON NECK AND UNDERARMS, HAIR LOSS, COLD/PAIN OF EXTREMITIES AND CHEST, WEIGHT GAIN, MALPOSITION OF IMPLANTS, BREAST DEFORMITIES, SCAR CONTRACTURES, ASYMMETRY OF IMPLANTS, VISIBLE IMPLANT OUTLINES, BREAST WRINKLING/RIPPLING, AND NUMBNESS AND TINGLING IN CHEST. (SAME RPTR REFERRED TO IN 1002459 - 1002461.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 REPLICON NATURAL Y POLYURETHANE COATED BREAST IMPLANT Implant FTR MEDICAL ENGINEERING CORP. 730416K, 726017

Patients

Seq Age Sex Outcome Treatment
1 *