BEUDAMED
    FDA Adverse Event Death Summary report: N

    BREAST IMPLANT

    MDR report key: 8754244 · Received July 1, 2019

    Report

    Report Number
    MW5087741
    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) 2015. TIME EXPOSED: 10 YEARS. COSMETIC INDICATION. PRESENTED WITH MASS / METS. EXPLANTATION, PARTIAL CAPSULECTOMY, AND AXILLARY CLEARANCE PERFORMED. PT RECEIVED CHEMOTHERAPY. CYTOLOGY: ALCL FOUND IN CAPSULE AND AXILLARY LNS. HISTOLOGY: MASS. DATE OF DEATH: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545266 BREAST IMPLANT PROSTHESIS, BREAST, NON-INFLATABL , INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN, INC. / MCGHAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death