BEUDAMED
    FDA Adverse Event Death Summary report: N

    BREAST IMPLANT

    MDR report key: 8754069 · Received July 1, 2019

    Report

    Report Number
    MW5087737
    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. EVENT OCCURRED IN (B)(6). ALCL ON RIGHT SIDE. DATE OF PROGRESSION: (B)(6) 2016. TIME EXPOSED: 10.4 YEARS. INDICATION: RECONSTRUCTION. PT PRESENTED WITH MASS. CAPSULECTOMY PERFORMED. PT RECEIVED CHEMOTHERAPY. DATE OF DEATH: (B)(6) 2016. CAUSE OF DEATH: BIA-ALCL. CYTOLOGY: CD30, CD4, ALK-. HISTOLOGY: MASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545341 BREAST IMPLANT PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN INC. / MCGHAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death