BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH HIGH PROFILE GEL MAMMARY PROSTHESES

    MDR report key: 2252752 · Received September 15, 2011

    Report

    Report Number
    1645337-2011-00029
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 21, 2011
    Report Date
    September 15, 2011
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER REQUEST BY THE FDA, I HAVE SPLIT REPORT 1645337-2011-00026 INTO TWO SEPARATE REPORTS.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH MENTOR IMPLANTS, THREE DAYS LATER SHE STARTED GETTING HIVES AT THE INFRAMAMMARY CREASE, WHICH THEN SPREAD TO HER ENTIRE CHEST. SHE WAS TREATED WITH BENADRYL AND STEROIDS. THE PT IS GETTING BETTER AND THEY ARE WINGING HER OFF OF THE STEROIDS. SHE IS NOT SURE IF THE DEVICES WILL BE REMOVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH HIGH PROFILE GEL MAMMARY PROSTHESES BREAST IMPLANT FTR MENTOR WORLDWIDE LLC 6481752

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other