BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE CONTOUR MAMMARY PROSTHESIS

    MDR report key: 176004 · Received July 2, 1998

    Report

    Report Number
    1645337-1998-00112
    Event Type
    Injury
    Date Received
    July 2, 1998
    Date of Event
    June 20, 1998
    Report Date
    June 25, 1998
    Manufacturer
    MENTOR
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SILTEX SALINE CONTOUR MAMMARY PROSTHESIS ON 7/20/1995, SUBSEQUENTLY THE PT EXPERIENCED BREAST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE CONTOUR MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FWM MENTOR NA 16331

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention