BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 8407744 · Received March 11, 2019

    Report

    Report Number
    9617229-2019-01521
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 4, 2019
    Report Date
    March 11, 2019
    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: TEVIS, ET AL. ¿DIFFERENCES IN HUMAN LEUKOCYTE ANTIGEN EXPRESSION BETWEEN BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA PATIENTS AND THE GENERAL POPULATION.¿ OUP ACADEMIC, OXFORD UNIVERSITY PRESS, 4 FEB. 2019, ACADEMIC.OUP.COM/ASJ/ADVANCE-ARTICLE-ABSTRACT/DOI/10.1093/ASJ/SJZ021/5306130. CLARIFICATION: 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 LYMPHOMA-ALCL AND SEROMA LATE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLED "DIFFERENCES IN HUMAN LEUKOCYTE ANTIGEN EXPRESSION BETWEEN BREAST IMPLANT-ASSOCIATED ALCL PATIENTS AND THE GENERAL POPULATION" REPORTED UNKNOWN SIDE "BIA-ALCL" AND "EFFUSION AROUND THE IMPLANT." MANUFACTURER OF THE DEVICE IS UNKNOWN. STATUS OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203705 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention