BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE MAMMARY PROSTHESIS

    MDR report key: 223190 · Received May 11, 1999

    Report

    Report Number
    1645337-1999-00102
    Event Type
    Injury
    Date Received
    May 11, 1999
    Date of Event
    January 15, 1999
    Report Date
    May 3, 1999
    Manufacturer
    MENTOR
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED BILATERALLY WITH SILTEX SALINE MAMMARY PROSTHESIS ON 9/15/1998. SUBSEQUENTLY, THE PT EXPERIENCED BILATERAL DEFLATION OF THE DEVICES, CAPSULAR CONTRACTURE AND PAIN. THE DEVICES WERE EXPLANTED ON 1/25/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FWM MENTOR NA 94918

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention