BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE CONTOURED LOW PROFILE GEL BREAST IMPLANT, 250

    MDR report key: 13596 · Received May 26, 1994

    Report

    Report Number
    MW1002262
    Date Received
    May 26, 1994
    Report Date
    May 23, 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 COMPLAINS OF SILICONE POUCH RIPPLING, IMPLANT LEAKAGE, CAPSULAR CONTRACTURE, LOW BACK PAIN, JOINT SWELLING, PAIN AND STIFFNESS, HARDENING OF SKIN AROUND IMPLANT, FINGER AND HAND SWELLING, BREAST TENDERNESS, GENERAL ACHING AND STIFFNESS OF BACK AND KNEES, SEVERE INSOMNIA, VISIBLE IMPLANT WRINKLES, ARM PAIN ON MOVEMENT, BREAST REDNESS AND INFLAMMATION, AND DEFORMED BREASTS. SHE CANNOT LIE ON HER STOMACH OR BACK. (SAME RPTR REFERRED TO IN 1002263.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE CONTOURED LOW PROFILE GEL BREAST IMPLANT, 250 Implant FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. STYLE 8000 165521

    Patients

    Seq Age Sex Outcome Treatment
    1 *