BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 8416444 · Received March 13, 2019

    Report

    Report Number
    9617229-2019-01606
    Event Type
    Injury
    Date Received
    March 13, 2019
    Report Date
    March 13, 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: CLEMENS, AND MARK W. ¿INTRODUCTION TO THE ¿CURRENT CONTROVERSIES IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL)" SUPPLEMENT.¿ OUP ACADEMIC, OXFORD UNIVERSITY PRESS, 31 JAN. 2019, ACADEMIC.OUP.COM/ASJ/ARTICLE/39/SUPPLEMENT_1/S1/5304921. THE EVENT OF LYMPHOMA-ALCL AND LYMPHADENOPATHY 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. [(B)(4)].

    Description of Event or Problem · 1

    JOURNAL ARTICLE "2019 NCCN CONSENSUS GUIDELINES ON THE DIAGNOSIS AND TREATMENT OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA" FIGURE 5 REPORTED CASE 3 HAD RIGHT SIDE "BIA-ALCL" AND "SUPRACLAVICULAR LYMPH NODE METASTASIS." NO PATHOLOGICAL MARKERS WERE PROVIDED. PATIENT RECEIVED CHEMOTHERAPY AS WELL AS SURGICAL RESECTION. DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209113 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention