BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE MAMMARY PROSTHESIS

    MDR report key: 168800 · Received May 18, 1998

    Report

    Report Number
    1645337-1998-00064
    Event Type
    Injury
    Date Received
    May 18, 1998
    Report Date
    May 12, 1998
    Manufacturer
    MENTOR
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BILATERALLY IMPLANTED WITH SILTEX SALINE MAMMARY PROSTHESIS ON 1/10/1994, SUBSEQUENTLY THE PT EXPERIENCED BILATERAL DEFLATION, CAPSULAR CONTRACTURE, PAIN, WRINKLING, DISPLACEMENT AND ASYMMETRY. THE DEVICES WERE REMOVED ON 4/3/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FWM MENTOR NA 83191 / NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention