BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY SALINE IMPLANT 300ML

    MDR report key: 1810767 · Received August 17, 2010

    Report

    Report Number
    MW5017133
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ALLERGAN MECUCAE
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    S/P MASTECTOMY. ON 08/03 EXCHANGE TISSUE EXPANDER FOR IMPLANT 08/06 FOUND SALINE IMPLANT DEFLATED. ON 08/07 BACK TO OPERATING ROOM FOR REMOVAL AND REPLACEMENT EXAMINED IMPLANT ON BACK TABLE / MD APPEARS NO CAUSE FOR DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY SALINE IMPLANT 300ML SALINE BREAST IMPLANT FWM ALLERGAN MECUCAE 15123966

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention