BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 7986266 · Received October 19, 2018

    Report

    Report Number
    9617229-2018-08278
    Event Type
    Death
    Date Received
    October 19, 2018
    Date of Event
    November 30, 2015
    Report Date
    October 19, 2018
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: "COMPLETE SURGICAL EXCISION IS ESSENTIAL FOR THE MANAGEMENT OF PATIENTS WITH BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA." MARK W. CLEMENS, L. JEFFREY MEDEIROS, CHARLES E. BUTLER, KELLY K. HUNT, MICHELLE A. FANALE, STEVEN HORWITZ, DENNIS D. WEISENBURGER, JUN LIU, ELIZABETH A. MORGAN, RASHMI KANAGAL-SHAMANNA, VINITA PARKASH, JING NING, ALIYAH R. SOHANI, JUDITH A. FERRY, NEHA MEHTA-SHAH, AHMED DOGAN, HUI LIU, NORA THORMANN, ARIANNA DI NAPOLI, STEPHEN LADE, JORGE PICCOLINI, RUBEN REYES, TRAVIS WILLIAMS, COLLEEN M. MCCARTHY, SUMMER E. HANSON, LORETTA J. NASTOUPIL, RAKESH GAUR, YASUHIRO OKI, KEN H. YOUNG, AND ROBERTO N. MIRANDA, JOURNAL OF CLINICAL ONCOLOGY, VOL. 34, NUMBER 2, JANUARY 10, 2016, P. 160-168. THIS EVENT IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN BOTH SALINE AND SILICONE LABELING. AS IT IS UNKNOWN WHETHER THE AFFECTED DEVICE IS SALINE OR SILICONE, NO DEVICE LABELING CAN BE SENT AT THIS TIME. THE EVENTS OF DEATH AND LYMPHOMA - ALCL ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THE EVENTS.

    Description of Event or Problem · 1

    REPORTED EVENT OF SIX PATIENTS EXPERIENCED LYMPHOMA - ALCL AND DEATH NOTED IN "COMPLETE SURGICAL EXCISION IS ESSENTIAL FOR THE MANAGEMENT OF PATIENTS WITH BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA". MANUFACTURER OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824225 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death