BEUDAMED
    FDA Adverse Event Summary report: N

    GEL SALINE PROSTHESIS

    MDR report key: 10662 · Received December 28, 1993

    Report

    Report Number
    MW1000231
    Date Received
    December 28, 1993
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD SECOND SET OF IMPLANTS INSERTED ON 6/19/87. DIAGNOSIS: STATUS POST FIRST STAGE BILATERAL BREAST RECONSTRUCTION (TISSUE EXPANSION). RPTR HAD REMOVAL OF TISSUE EXPANDERS, INTERNAL CAPSULOTOMIES AND INSERTION OF THESE IMPLANTS. RPTR EXPERIENCED RHEUMATOID ARTHRITIS, CAPSULAR CONTRACTURES, CARCINOMA, ARTHRITIS WITH SYMPTOMS, JOINT SWELLING, PAIN, STIFFNESS, MUSCLE FATIGUE, SWELLING OF HANDS AND FINGERS, FATIGUE, BREAST TENDERNESS, GENERAL ACHING AND STIFFNESS, SWOLLEN GLANDS, TINGLING OF EXTREMITIES, INCORRECT SIZES OF IMPLANTS WITH ASYMMETRY, VISIBLE WRINKLES, HARDNESS OF BREASTS, IMPLANT NOISES, NUMEROUS OPERATIONS, FOREIGN GIANT CELL REACTION, SCARING, BACK AND KNEE STIFFNESS, MORNING STIFFNESS AND SALINE LEAKAGE. (SAME RPTR REFERRED TO IN 1000230, 100232 AND 1000233.) INSERTION OF TISSUE EXPANDER. SHE HAD OPEN CAPSULOTOMY, RIGHT RECONSTRUCTED BREAST. EXPANDER WAS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL SALINE PROSTHESIS FTR MCGHAN MEDICAL CORP. STYLE 56

    Patients

    Seq Age Sex Outcome Treatment
    1 *