BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC(R) II MAMMARY IMPLANT, H.P. HPR

    MDR report key: 55666 · Received December 11, 1996

    Report

    Report Number
    1816403-1996-00352
    Event Type
    Injury
    Date Received
    December 11, 1996
    Date of Event
    November 11, 1996
    Report Date
    November 12, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: - WEIGHT MEASUREMENT RESULTS: - CREASE LINES - SLIGHT AMBER COLOR - WEIGHT MEASUREMENT CONCLUSIONS: - COLOR WITHIN SPECIFICATIONS - CREASES AND WEAR RESULT OF FOLDING ACTION IN-VIVO - WEIGHT WITHIN SPECIFICATION LIMITS.

    Description of Event or Problem · 1

    RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC(R) II MAMMARY IMPLANT, H.P. HPR Implant MAMMARY IMPLANT, GEL FILLED FTR DOW CORNING CORP NA HH046274

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention