BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY PROSTHESIS CRONIN CONTOUR SEAMLESS FP

    MDR report key: 38418 · Received September 13, 1996

    Report

    Report Number
    1816403-1996-00058
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    January 1, 1986
    Report Date
    August 14, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3-THE LEFT DEVICE WAS RETURNED TO DOW CORNING FOR ID PURPOSES ONLY AND UPON VISUAL EXAMINATION THE CONDITION OF THE IMPLANT APPEARED TO BE INTACT WITH UNK SHELL INTEGRITY. THE DEVICE WAS THEN RETURNED TO AUSTRALIA ON AUG. 15, 1996 WITHOUT FURTHER EVALUATION.

    Description of Event or Problem · 1

    REPORT ALLEGES PATIENT BEGAN EXPERIENCING PAIN AND HARDNESS IN APPROX. 1986 AND DISTORTION AND INTRACAPSULAR RUPTURE IN APPROX. 1994.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY PROSTHESIS CRONIN CONTOUR SEAMLESS FP Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R