BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM CONTOUR POST-OPERATIVELY ADJUSTABLE MAMMARY PROSTHE

    MDR report key: 172866 · Received June 15, 1998

    Report

    Report Number
    1645337-1998-00082
    Event Type
    Injury
    Date Received
    June 15, 1998
    Date of Event
    April 26, 1998
    Report Date
    April 28, 1998
    Manufacturer
    MENTOR
    Product Code
    FWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SPECTRUM CONTOUR POST-OPERATIVELY ADJUSTABLE MAMMARY PROSTHESIS ON 12/19/1995. SUBSEQUENTLY, THE PT EXPERIENCED BREAST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM CONTOUR POST-OPERATIVELY ADJUSTABLE MAMMARY PROSTHE Implant MAMMARY PROSTHESIS FWM MENTOR NA 130847

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention