BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE ROUND SILASTIC BREAST IMPLANT 425/30 CC

    MDR report key: 12928 · Received April 25, 1994

    Report

    Report Number
    MW1001726
    Date Received
    April 25, 1994
    Report Date
    April 20, 1994
    Manufacturer
    MENTOR 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 KNEE PAIN AND SWELLING, JOINT PAIN, DIFFICULTY RAISING HANDS OVER HEAD, IMPLANT RUPTURE, DIFFUCULTY SLEEPING, CAPSULAR CONTRACTURE, IMPLANT AGING AND DEGENERATION, ARTHRITIS SYMPTOMS OF HANDS, ELBOWS, AND KNEES, MUSCLE FATIGUE, HAND AND FINGER SWELLING, BREAST TENDERNESS, FATIGUE, COLDNESS AND PAIN OF EXTREMITIES, IMPLANT MIGRATION UNDER ARMS. (ALSO SEE 1001727.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE ROUND SILASTIC BREAST IMPLANT 425/30 CC FTR MENTOR CORP. 7000 226692

    Patients

    Seq Age Sex Outcome Treatment
    1 *