BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK MAMMARY PROSTHESIS

    MDR report key: 13446 · Received May 23, 1994

    Report

    Report Number
    MW1002161
    Date Received
    May 23, 1994
    Date of Event
    September 16, 1987
    Report Date
    May 12, 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 PLEURISY, MUSCLE INFLAMMATION AND SPASMS, DRY VAGINA, JOINT SWELLING, MUSCLE ACHES, PAINS AND WEAKNESS, HAIR LOSS, AND COLON PROBLEMS. (SAME RPTR REFERRED TO IN 1002159 AND 1002160.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 41194-87H

    Patients

    Seq Age Sex Outcome Treatment
    1 *