BEUDAMED
    FDA Adverse Event Death Summary report: N

    BREAST IMPLANTS

    MDR report key: 8753960 · Received July 1, 2019

    Report

    Report Number
    MW5087735
    Event Type
    Death
    Date Received
    July 1, 2019
    Manufacturer
    ALLERGAN INC. / MCGHAN
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT OF AN ALCL RELATED DEATH WAS REPORTED BY DR (B)(6) TO FDA ON 06/24/2019. PT RECEIVED IMPLANTS FOR RECONSTRUCTION. PT PRESENTED WITH A SEROMA. DATE OF PROGRESSION: (B)(6) 2007. A CAPSULECTOMY WAS PERFORMED. PT RECEIVED RADIATION THERAPY AND CHEMOTHERAPY. DATE OF DEATH IS (B)(6) 2012. CAUSE OF DEATH IS BIA-ALCL. CYTOLOGY: CD30+, CD4+, CD43+ ALK-. HISTOLOGY: MASS - INCOMPLETE RESECTION. TIME EXPOSED IS 8 YEARS. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545228 BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN INC. / MCGHAN
    545229 BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN INC. / MCGHAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death