BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK MAMMARY PROSTHESIS

    MDR report key: 13454 · Received May 23, 1994

    Report

    Report Number
    MW1002169
    Date Received
    May 23, 1994
    Date of Event
    March 9, 1984
    Report Date
    May 13, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF DRY VAGINA, JOINT TENDERNESS, MUSCLE ACHES, PAINS AND WEAKNESS, LOSS OF MEMORY AND REFLEX, CHRONIC FATIGUE, NIGHT SWEATS, LOW GRADE FEVERS, EYE PROBLEMS, AND TINGLING IN LEGS, ARMS, EYEBROWS, HANDS AND FEET. (SAME RPTR REFERRED TO IN 1002170.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 8815-84-A, 9989-83-G

    Patients

    Seq Age Sex Outcome Treatment
    1 *