BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE MAMMARY IMPLANT

    MDR report key: 168788 · Received May 18, 1998

    Report

    Report Number
    1645337-1998-00061
    Event Type
    Injury
    Date Received
    May 18, 1998
    Date of Event
    December 1, 1997
    Report Date
    April 29, 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 ON 9/13/1993 WITH A SILTEX SALINE MAMMARY PROSTHESIS, SUBSEQUENTLY THE PT EXPERIENCED CAPSULAR CONTRACTURE, INFECTION AND PAIN. THE DEVICE WAS REMOVED ON 1/22/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE MAMMARY IMPLANT Implant MAMMARY PROSTHESIS FWM MENTOR NA 82945

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention