BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN NATRELLE SALINE-FILLED BREAST IMPLANT

    MDR report key: 6066239 · Received October 31, 2016

    Report

    Report Number
    6066239
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ALLERGAN. INC.
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEFT BREAST RUPTURED IMPLANT REMOVED. CHART REVIEWED: ABOUT EIGHT YEARS AGO UNDERWENT A BILATERAL BREAST AUGMENTATION USING SUBMUSCULAR SALINE IMPLANTS FROM INFRAMAMMARY CREASE INCISION LINE. THE PATIENT RECOVERED WELL FROM THAT SURGERY. SHE WAS VERY CONTENT WITH HER POST-OP COURSE. THE PATIENT RECENTLY PRESENTED WITH A SUDDEN DEFLATION OF HER LEFT BREAST IMPLANT. SHE REPORTS THAT SHE HAS HAD NO ANTECEDENT HISTORY FOR TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717936 MCGHAN NATRELLE SALINE-FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE LCJ ALLERGAN. INC. 1541123

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R