BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH SALINE

    MDR report key: 77918 · Received March 20, 1997

    Report

    Report Number
    1645337-1997-00008
    Event Type
    Injury
    Date Received
    March 20, 1997
    Date of Event
    September 23, 1996
    Report Date
    March 19, 1997
    Manufacturer
    MENTOR H/S
    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 WITH A SALINE PROSTHESIS ON 9/20/96, SUBSEQUENTLY IT WAS NOTED THAT THE PT HAD DEVELOPED PAIN AND AN INFECTION IN HER LEFT BREAST AND THE PROSTHESIS WAS REMOVED ON 1/17/97. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, FEBRUARY 10, 1992). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PR21CFR803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH SALINE Implant MAMMARY PROSTHESIS FWM MENTOR H/S NA 150221

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention