BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 11668940 · Received April 15, 2021

    Report

    Report Number
    9617229-2021-06185
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 13, 2021
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: AMADOR, CATALINA, FELDMAN, ANDREW. HOW I DIAGNOSE ANAPLASTIC LARGE CELL LYMPHOMA. AMERICAN JOURNAL OF CLINICAL PATHOLOGY. 2021; 479-497. (B)(4). THE EVENTS OF LYMPHOMA - ALCL, LYMPHADENOPATHY, AND LUMP/NODULE 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. REASON FOR REOPERATION: CD30+, ALK- BIA-ALCL; RIGHT AXILLARY LYMPHADENOPATHY; NODULARITY; ASSOCIATED MASS IN THE RIGHT CAPSULECTOMY SPECIMEN.

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE ¿HOW I DIAGNOSE ANAPLASTIC LARGE CELL LYMPHOMA¿ AUTHORS REPORT A (B)(6)-YEAR-OLD PATIENT WHO UNDERWENT EXCISIONAL LYMPH NODE BIOPSY FOR RIGHT AXILLARY LYMPHADENOPATHY WITHOUT OTHER CLINICAL HISTORY PROVIDED. SECTIONS OF THE LYMPH NODE SHOWED AN ATYPICAL LYMPHOID INFILTRATE WITH A SINUSOIDAL GROWTH PATTERN COMPOSED OF LARGE PLEOMORPHIC CELLS, INCLUDING HALLMARK CELLS WITH RENIFORM NUCLEI. THE NEOPLASTIC CELLS WERE POSITIVE FOR CD30 AND NEGATIVE FOR ALK. THE CASE WAS SIGNED OUT AS ALK-NEGATIVE ALCL. SUBSEQUENTLY, THE PATIENT WAS EVALUATED BY A HEMATOLOGIST/ ONCOLOGIST WHO RAISED CONCERN ABOUT BREAST IMPLANT-ASSOCIATED ALCL (BIA-ALCL), AS THE PATIENT HAD A HISTORY OF BILATERAL MASTECTOMY WITH IMPLANT PLACEMENT FOR BREAST CARCINOMA 10 YEARS PREVIOUSLY AND HAD NOTED HARDNESS AND SWELLING OF THE RIGHT BREAST FOR THE PAST 6 MONTHS. PET SCAN SHOWED NO DISEASE BEYOND THE RIGHT AXILLARY REGION AND BREAST. THE BREAST IMPLANTS WERE REMOVED AND SHOWED GROSS ADHESIONS, NODULARITY, AND AN ASSOCIATED MASS IN THE RIGHT CAPSULECTOMY SPECIMEN. HISTOLOGIC SECTIONS SHOWED LARGE PLEOMORPHIC CELLS WITH MORPHOLOGY AND PHENOTYPE SIMILAR TO THOSE SEEN IN THE LYMPH NODE EXCISION. GIVEN THE ADDITIONAL FINDINGS, THE FINAL DIAGNOSIS WAS AMENDED TO BIAALCL WITH EXTENSION TO THE REGIONAL LYMPH NODES. THE MANUFACTURER OF THE DEVICE IS UNKNOWN. AFFECTED SIDE IS RIGHT. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571365 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R