BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN

    MDR report key: 519211 · Received March 29, 2004

    Report

    Report Number
    519211
    Event Type
    Malfunction
    Date Received
    March 29, 2004
    Date of Event
    March 25, 2004
    Report Date
    March 29, 2004
    Manufacturer
    *
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REMOVE AND REPLACE DEFLATED LEFT SALINE BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN SALINE BREAST IMPLANT FWM * UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other