BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE MAMMARY PROSTHESIS

    MDR report key: 188965 · Received September 21, 1998

    Report

    Report Number
    1645337-1998-00174
    Event Type
    Injury
    Date Received
    September 21, 1998
    Date of Event
    May 28, 1998
    Report Date
    June 1, 1998
    Manufacturer
    MENTOR
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SILTEX SALINE MAMMARY PROSTHESIS ON 5/18/1994. SUBSEQUENTLY, THE PT EXPERIENCED A DEFLATION OF THE PROSTHESIS AND PAIN IN THE BREAST. THE DEVICE WAS REMOVED ON 6/3/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FWM MENTOR NA 94050

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention