BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH SALINE (OVAL)

    MDR report key: 106922 · Received July 18, 1997

    Report

    Report Number
    1645337-1997-00088
    Event Type
    Injury
    Date Received
    July 18, 1997
    Report Date
    July 9, 1997
    Manufacturer
    MENTOR H/S
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BILATERALLY IMPLANTED WITH SMOOTH SALINES ON 3/20/97. SUBSEQUENTLY, IT WAS NOTED THAT THE PROSTHESIS HAD MIGRATED AND BOTH WERE REMOVED ON 5/5/97. 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 PER 21CFR803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH SALINE (OVAL) Implant MAMMARY PROSTHESIS FWM MENTOR H/S NA 150814/150814

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention