BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST IMPLANTS

    MDR report key: 641836 · Received October 12, 2005

    Report

    Report Number
    641836
    Event Type
    Malfunction
    Date Received
    October 12, 2005
    Date of Event
    September 22, 2005
    Report Date
    October 11, 2005
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2005 DR WILL REPLACE THE LEFT BREAST WITH A NEW IMPLANT AS THE OLD IMPLANT DEFLATED. IMPLANTS WILL BE RETURNED TO MFR AND PT WILL BE CREDITED. IN 8/30/2001, DR IMPLANTED 27-FM120-310A MCGHAN IMPLANT, LOT 102282 AND EXPLANTED ON 9/22/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST IMPLANTS CENTRAL/PLASTIC SURGERY FWM MCGHAN MEDICAL CORP 27-FM-310-A 102282

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other