BEUDAMED
    FDA Adverse Event Summary report: N

    SILASTIC MSI MAMMARY IMPLANT HP

    MDR report key: 3143264 · Received March 11, 2013

    Report

    Report Number
    3143264
    Date Received
    March 11, 2013
    Report Date
    March 6, 2013
    Manufacturer
    DOW CORNING WRIGHT
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAST BREAST PROCEDURE FOR PATIENT WAS (B)(6) 1990 - IMPLANT OF BIO ELASTIC BREAST PROSTHESIS. THROUGHOUT THE ENSUING YEARS, PT C/O PAIN AND FINALLY ELECTED FOR REMOVAL OF IMPLANTS TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102676 SILASTIC MSI MAMMARY IMPLANT HP BREAST IMPLANT FTR DOW CORNING WRIGHT P044-0425 RT M526780 LT M526780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention