BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 440798 · Received January 28, 2003

    Report

    Report Number
    440798
    Event Type
    Malfunction
    Date Received
    January 28, 2003
    Date of Event
    January 28, 2003
    Report Date
    January 28, 2003
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BREAST AUGMENTATION WITH SALINE FILLED IMPLANTS DONE IN 1993-LEFT IMPLANT DEFLATED. IN 2003 LEFT IMPLANT REMOVED & REPLACED WITH SALINE FILLED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP SALINE FILLED BREAST IMPLANT LEFT FWM MCGHAN MEDICAL CORP 168 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other