BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK GEL MAMMARY IMPLANT

    MDR report key: 123601 · Received September 30, 1997

    Report

    Report Number
    2182596-1997-00577
    Event Type
    Injury
    Date Received
    September 30, 1997
    Report Date
    August 4, 1997
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGATIONS OF FATIGUE, JOINT TENDERNESS, ELEVATED ICG, IGA & ESR, CAPSULAR CONTRACTURE, RUPTURED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK GEL MAMMARY IMPLANT Implant GEL MAMMARY IMPLANT FTR MEDICAL ENGINEERING CORP. 1145000 70652-88A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention