BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7240638

    MDR report key: 7240638 · Received February 5, 2018

    Report

    Report Number
    7240638
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 1, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SILICONE-FILLED BREAST IMPLANT WAS DEFECTIVE, TAKEN TO PATHOLOGY FOR GROSS EXAM THEN RETURN TO MANAGEMENT TO RETURN TO MANUFACTURER. PER MD OP REPORT: "SMALL SPOT NOTED ON NEW IMPLANT JUST PUT IN PATIENT....WAS A DEFECT IN RELATIVELY CONSISTENT TEXTURE OF IMPLANT ...NO GEL LEAK NOTED".

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other