BEUDAMED
    FDA Adverse Event Other Summary report: N

    I AMED AESTHETICS

    MDR report key: 565671 · Received January 13, 2005

    Report

    Report Number
    565671
    Event Type
    Other
    Date Received
    January 13, 2005
    Date of Event
    January 10, 2005
    Report Date
    January 12, 2005
    Manufacturer
    I AMED
    Product Code
    FWM
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD LEFT SALINE BREAST IMPLANT THAT WAS DEFLATED AND HAD TO BE REPLACED. LEFT BREAST IMPLANT PLACED IN 1995.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I AMED AESTHETICS SALINE BREAST IMPLANT FWM I AMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other