BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMOOTH SALINE

    MDR report key: 39151 · Received September 18, 1996

    Report

    Report Number
    1645337-1996-00011
    Event Type
    Death
    Date Received
    September 18, 1996
    Report Date
    September 17, 1996
    Manufacturer
    MENTOR H/S
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BILATERALLY IMPLANTED WITH SALINE PROSTHESIS ON 5/17/93. SUBSEQUENTLY THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AUTO-IMMUNE TYPE SYSTEMS, SUCH AS LUPUS, ARTHRITIS, IRRITABLE BOWLS AND CHANGE IN TEXTURE OF SKIN ALONG WITH WRINKLING OF BOTH IMPLANTS. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH SALINE Implant MAMMARY PROSTHESIS FWM MENTOR H/S NA 74932 /74932

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention