BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK ADJUSTABLE RECONSTRUCTIVE BILUMEN IMPLANT

    MDR report key: 13920 · Received June 10, 1994

    Report

    Report Number
    MW1002432
    Date Received
    June 10, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF CAPSULAR CONTRACTURE. (SAME RPTR REFERRED TO IN 1002433, 1002434, AND 1002435.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK ADJUSTABLE RECONSTRUCTIVE BILUMEN IMPLANT Implant SILICONE BILUMEN IMPLANT FTR MEDICAL ENGINEERING CORP. 59722-86-H, 59723-86-H

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR