BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN HEYER- SCHULTE

    MDR report key: 973011 · Received December 28, 2007

    Report

    Report Number
    973011
    Event Type
    Injury
    Date Received
    December 28, 2007
    Date of Event
    December 18, 2007
    Report Date
    December 27, 2007
    Manufacturer
    UNKNOWN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT BILATERAL REVISION OF A BREAST RECONSTRUCTION WITH REMOVAL OF SILICONE BREAST IMPLANTS AND BILATERAL CAPSULECTOMIES DUE TO RECENT CHANGES IN THE BREAST RECONSTRUCTIONS SUGGESTIVE OF IMPLANT RUPTURES. THE RIGHT IMPLANT WAS NOTED TO HAVE TOTAL DISINTEGRATION OF THE CAPSULE WITH EXTRUDED GEL SILICONE. BOTH IMPLANTS WERE EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN HEYER- SCHULTE SILICONE BREAST IMPLANTS FTR UNKNOWN 10522320

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R