BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 2130419 · Received June 13, 2011

    Report

    Report Number
    2024601-2011-00523
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    January 1, 2004
    Report Date
    May 20, 2011
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED: (B)(4) 2011.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LEFT SIDE INFLATION OF APPROXIMATELY 500CC MORE FLUID IN THE IMPLANT. AT THE TIME OF IMPLANTATION, NORMAL SALINE WAS USED TO FILL THE DEVICE. IT WAS EXPLAINED THAT THE PT DID NOT HAVE ANY ADDITIONAL FILLS BY ANOTHER SURGEON. THE PT PRESENTS WITH NOTICEABLE SWELLING ON THE LEFT SIDE. A FOLLOW-UP CALL WAS PLACED AGAIN TO THE OFFICE THE STAFF INFORMS ME THAT THE SURGEON "PULLED OF APPROXIMATELY 500CC OF FLUID TO MAKE THE PT LOOK EVEN." A FEW WEEKS LATER, THEY REMOVED THE IMPLANT AND REPLACED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SALINE IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention