FDA Adverse Event Summary report: N

HEYER-SCHULTE RADOVAN TISSUE EXPANDER, 400 CC

MDR report key: 11054 · Received January 25, 1994

Report

Report Number
MW1000484
Date Received
January 25, 1994
Report Date
January 14, 1994
Manufacturer
MENTOR CORP.
Product Code
LCJ
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

RPTR HAD A RIGHT MODIFIED MASTECTOMY ON 5/13/85. ON 6/5/86, SHE HAD ANOTHER CO'S TISSUE EXPANDERS IMPLANTED AND ON 6/17/87 SHE HAD THE EXPANDERS REPLACED WITH A SECOND CO'S IMPLANTS. THIS CO'S EXPANDERS WERE IMPLANTED ON 6/17/87. THEY WERE REMOVED AND REPLACED ON 9/16/87 WITH SILICONE IMPLANTS. RPTR HAS NOTED/SUSPECTED THE FOLLOWING PROBLEMS: CARCINOMA OF RIGHT BREAST, FIBROCYSTIC OF LEFT, IMPLANT TIGHTNESS, SEVERE CAPSULE FORMATION, RIGHT NIPPLE UNNATURAL IN APPEARANCE, BREAST DRAINAGE, DEPRESSION, FATIGUE, ARM, FINGER AND SHOULDER PAIN, EXPANDERS SHIFTED, OPEN CAPSULOTOMIES, RUPTURE, BREAST SWELLING, BACK PAIN, ACHING ALL OVER, FIBROMYALGIA AND CARPAL TUNNEL, BURSITIS, SCAR CONTRACTURE, MILD ANKYLOSING SPONDYLITIS, CHRONIC MILD MYOFASCIAL SYNDROME, FIRST IMPLANTS LOOKED AWFUL, RIGHT SIDE WAS HARD AND HAD A LOT OF PAIN, HAD BACK AND SHOULDER PAIN, BURNING, SEARING PAIN IN LEFT BREAST BEFORE SECOND IMPLANTS WERE REMOVED. COULDN'T STAND TO MOVE ARM, IT HURT TO BREATH, MIGRAINES, HIGH BLOOD PRESSURE, ALLERGIES, ULCER, ANXIETY AND PANIC ATTACKS, MULTIPLE BREAST SURGERIES, ARTHRITIS AND SYMPTOMS, JOINT SWELLING, PAIN AND STIFFNESS, MUSCLE FATIGUE, SWELLING OF HANDS/FINGERS, BREAST TENDERNESS, COLDNESS/PAIN EXTREMITIES, INCORRECT SIZE OF IMPLANTS, SLOSHING NOISES, BREAST LUMPS AFTER IMPLANTS, SHAKING, DOESN'T SLEEP AT NIGHT AND EMOTIONAL. (ALSO SEE MEDWATCH 1000482, 1000483 AND 1000485.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HEYER-SCHULTE RADOVAN TISSUE EXPANDER, 400 CC LCJ MENTOR CORP. 13431

Patients

Seq Age Sex Outcome Treatment
1 *