BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH SALINE MAMMARY PROSTHESIS

    MDR report key: 227019 · Received June 4, 1999

    Report

    Report Number
    1645337-1999-00124
    Event Type
    Injury
    Date Received
    June 4, 1999
    Date of Event
    April 14, 1999
    Report Date
    June 2, 1999
    Manufacturer
    MENTOR
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SMOOTH SALINE MAMMARY PROSTHESIS IN 1988. SUBSEQUENTLY, THE PT EXPERIENCED CAPSULAR CONTRACTURE, INFECTION, AND DEFLATION OF THE DEVICE. THE DEVICE WAS EXPLANTED IN 05/13/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH SALINE MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FWM MENTOR NA 24206

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention