BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE MAMMARY PROSTHESIS

    MDR report key: 13321 · Received May 18, 1994

    Report

    Report Number
    MW1002054
    Date Received
    May 18, 1994
    Date of Event
    December 6, 1977
    Report Date
    May 11, 1994
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    HNR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF BURNING PAIN IN CHEST, DRY VAGINA, HANDS TURN WHITE IN COLD, JOINT SWELLING AND TENDERNESS, MUSCLES ACHES, PAINS AND WEAKNESS, LOSS OF MEMORY, REFLEX, BALANCE AND SENSATION, HAIR LOSS, PHOTOSENSITIVITY, SLEEP DISTURBANCE, EASY BRUISING, TROUBLE SWALLOWING, BLADDER AND COLON PROBLEMS, CHRONIC FATIGUE, NIGHT SWEATS, EYE PROBLEMS, AND TINGLING IN LEGS, ARMS AND HANDS. (SEE ALSO 1002055 AND 1002056.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE MAMMARY PROSTHESIS Implant HNR V. MUELLER DIV. BAXTER HEALTHCARE CORP. 134299

    Patients

    Seq Age Sex Outcome Treatment
    1 *