BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 19130255 · Received April 18, 2024

    Report

    Report Number
    9617229-2024-06648
    Event Type
    Injury
    Date Received
    April 18, 2024
    Report Date
    April 17, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: S. REHMAN1, F. SINGH1, A. TALWALKAR1, S. IRAM1, K. ZACHARIOUDAKIS2; BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): A MASS BUT NO FLUID, 2024; 105-106. THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: LUMP/NODULE AND LYMPHOMA-ALCL-SUSPECTED.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): A MASS BUT NO FLUID," A PATIENT WAS REPORTED TO HAVE EXPERIENCE "LUMP IN UPPER INNER QUADRANT OF LEFT BREAST," SOFT TISSUE MASS' AND 'A CONSPICUOUS POPULATION OF ATYPICAL SMALL TO MEDIUM TO OCCASIONAL LARGE NEOPLASTIC BF1 POSITIVE CD4 PREPONDERANT T-LYMPHOCYTES, WHICH SHOW STRONG DIFFUSE CD30 EXPRESSION. THESE FEATURES WERE REGARDED TO BE COMPATIBLE WITH BIA-ALCL'. PATHOLOGICAL MARKER CD30+ HAS BEEN RECEIVED. PATHOLOGICAL MARKER ALK- HAS NOT BEEN RECEIVED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539441 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention