BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRUM SALINE BREAST IMPLANT

    MDR report key: 1641131 · Received March 22, 2010

    Report

    Report Number
    1645337-2010-00017
    Event Type
    Other
    Date Received
    March 22, 2010
    Date of Event
    February 13, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH EXPIRED PRODUCT. DOCTOR'S CONCERN IS THAT THE LABEL INFO ABOUT STERILITY IS NOT ADEQUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM SALINE BREAST IMPLANT BREAST PROSTHESIS FWM MENTOR NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other