FDA Adverse Event Summary report: N

HEYER-SCHULTE MAMMARY PROSTHESIS, 250 CC

MDR report key: 17121 · Received October 24, 1994

Report

Report Number
MW1003783
Date Received
October 24, 1994
Report Date
February 11, 1994
Manufacturer
V. MUELLER DIV. BAXTER HEALTHCARE CORP.
Product Code
FTR
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

RPTR HAD BILATERAL FIBROCYSTDISEASE. SHE HAD A SUBCUTANEOUS MASTECTOMY WITH INSERTION OF THESE IMPLANTS ON 1/29/81. ON 3/30/81, THE LEFT IMPLANT WAS REMOVED. SHE HAD AN INCISION AND DRAINAGE. SUDDEN GUSH OF HEMATOMA EXTRUDED CAUSING A LITTLE RUPTURE OF THE IMPLANT. IN ADDITION RPTR COMPLAINS OF THE FOLLOWING: FIBROCYSTIC BREASTS, CHRONIC INFLAMMATION/FOREIGN GIANT CELL GRANULOMA, LIPOMA BREAST: DEFORMITIES, DISCOMFORT, PAIN, MULTIPLE OPERATIONS, CAPSULAR CONTRACTURES, HEMATOMAS, BRUISING, DISCOLORATION, SEVERE PAIN, ADHESIONS, SWELLING, ASYMMETRY, IMPLANT FOLDS, EXCESSIVE BLEEDING, IMPLANT WRINKLES, INCORRECT SIZE OF IMPLANTS, ASYMMETRY, MALPOSITION OF IMPLANTS, VISIBLE WRINKLES OF IMPLANTS, SLOSHING NOISES FROM IMPLANTS, CLOSED CAPSULOTOMIES 3/16/81, 3/30/81, 1/29/82 - UNSUCCESSFUL, 3/2/82 - UNSUCCESSFUL, ARM AND SHOULDER DISCOMFORT, CHEST PAIN (PROBABLY GI OR MUSCULOSKELETAL, TMJ, APICAL SYSTOLIC MURMUR, BREAST MASSES, BACK PAIN AND HEMATURIA, CHRONIC ARTHRITIC SYMPTOMS IN NECK, BACK, CHEST, ARMS, SWOLLEN LYMPH NODES IN NECK, SINUSITIS, RIGHT LUNG PAIN, IMPLANT RUPTURES, NEUROFIBROMAS, JOINT SWELLING, PAIN AND STIFFNESS, MUSCLE FATIGUE, HARDENING OF SKIN AROUND IMPLANT, SWELLING OF FINGERS AND HANDS, UNEXPLAINED RASHES, BREAST TENDERNESS, FATIGUE, GENERAL ACHING AND STIFFNESS, HAIR LOSS, AND COLDNESS AND PAIN OF EXTREMITIES, RAYNAUDS, FIBROMYALGIA AND NON-SPECIFIC AUTO-IMMUNE CONDITION. (ALSO SEE 1003784-1003787.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HEYER-SCHULTE MAMMARY PROSTHESIS, 250 CC Implant BREAST IMPLANT FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. STYLE 7000 ROUND 214566

Patients

Seq Age Sex Outcome Treatment
1 *