BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE MAMMARY PROSTHESIS

    MDR report key: 188976 · Received September 21, 1998

    Report

    Report Number
    1645337-1998-00179
    Event Type
    Injury
    Date Received
    September 21, 1998
    Date of Event
    August 7, 1998
    Report Date
    August 21, 1998
    Manufacturer
    MENTOR
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BILATERALLY IMPLANTED WITH SILTEX SALINE MAMMARY PROSTHESES ON 11/10/1992. SUBSEQUENTLY, THE PT EXPERIENCED DEFLATION OF THE LEFT DEVICE AND CAPSULAR CONTRACTURE AND PAIN OF THE RIGHT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FWM MENTOR NA 70472 / 68186

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention