BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECTA-SPAN TISSUE EXPANDER

    MDR report key: 10661 · Received December 28, 1993

    Report

    Report Number
    MW1000230
    Date Received
    December 28, 1993
    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 FIRST SET OF IMPLANTS ON 3/25/87 DUE TO POST LEFT MASTECTOMY WITH FIBROCYSTIC DISEASE AND PARKINSON-WHITE SYNDROME. RIGHT SUBCUTANEOUS MASTECTOMY, BILATERAL FIRST STAGE BREAST RECONSTRUCTION BY PECTORALIS MAJOR AND ANTERIOR MUSCLE FLAPS AND INSERTION OF THESE IMPLANTS. ON 5/12/87, RPTR HAD DIAGNOSIS OF DEFORMITY OF RIGHT BREAST, STATUS-POST INSERTION OF TISSUE EXPANDER. SHE HAD OPEN CAPSULOTOMY, RIGHT RECONSTRUCTED BREAST. EXPANDER WAS PARTIALLY EMPTIED, AND THIS WAS DELIVERED THROUGH INCISION. SEVERE CAPSULAR CONTRACTURE OF ROUND EDGES WAS DISSECTED AND EXPANDER WAS REINSERTED. EXPANSION DONE TO A TOTAL OF 100 CC ON RIGHT, AND 100 CC OF SALINE ON LEFT. 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 SIZE 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 1000231-1000233.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECTA-SPAN TISSUE EXPANDER LCJ MENTOR CORP. 17392, 17419

    Patients

    Seq Age Sex Outcome Treatment
    1 *