BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX BECKER EXPANDER/MAMMARY PROSTHESIS

    MDR report key: 199387 · Received November 24, 1998

    Report

    Report Number
    1645337-1998-00251
    Event Type
    Injury
    Date Received
    November 24, 1998
    Date of Event
    October 20, 1997
    Report Date
    February 17, 1998
    Manufacturer
    MENTOR
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SILTEX BECKER EXPANDER/MAMMARY PROSTHESIS ON 11/24/1992. SUBSEQUENTLY, THE PT EXPERIENCED A RUPTURE OF THE DEVICE AND A SEROMA. THE DEVICE WAS REMOVED ON 12/11/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX BECKER EXPANDER/MAMMARY PROSTHESIS Implant EXPANDER/MAMMARY PROSTHESIS FTR MENTOR NA 66221

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention