BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST SALINE IMPLANT

    MDR report key: 1980190 · Received January 31, 2011

    Report

    Report Number
    MW5019256
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MCGHAN
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL REMOVAL AND REPLACEMENT OF SALE BREAST IMPLANTS DONE ON (B)(6) 2011. PT HAD RUPTURED LEFT SALINE IMPLANT, WHICH APPEARED TO BE FROM MARGINAL FOLD FATIGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST SALINE IMPLANT BILATERAL BREAST SALINE IMPLANTS, 360 ML FWM MCGHAN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization