BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 12800501 · Received November 11, 2021

    Report

    Report Number
    9617229-2021-57553
    Event Type
    Death
    Date Received
    November 11, 2021
    Date of Event
    January 1, 2019
    Report Date
    November 11, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF "GRADUAL DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: "GRADUAL DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA". THIS MDR IS ONE OF 13 TOTAL UNSUBSTANTIATED REPORTS BEING SUBMITTED FOR THE EVENT OF "13 PATIENTS DIED" OF "GRADUAL DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA". THE OTHER MDRS RELATED TO THIS EVENT ARE THE FOLLOWING: 9617229-2021-57530, 9617229-2021-57531, 9617229-2021-57551, 9617229-2021-57552, 9617229-2021-56301, 9617229-2021-57554, 9617229-2021-57555, 9617229-2021-57556, 9617229-2021-57532, 9617229-2021-57534, 9617229-2021-57535, 9617229-2021-57533.

    Description of Event or Problem · 0

    POSTER REPORTED "ACCIDENT WHICH LED TO THE GRADUAL DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA AND 13 PEOPLE DIED" FOR AN UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN. PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690701 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death