BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 15901832 · Received December 2, 2022

    Report

    Report Number
    9617229-2022-22027
    Event Type
    Injury
    Date Received
    December 2, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: XAVIER-JUNIOR JCC, CAMILO-JUNIOR DJ, KATSUDA PG, OKIDA RC. "CASE REPORT OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA CONFINED BY FIBROUS CAPSULE." HISTOPATHOLOGY. 2021. 81 (SUPPL. S1), 34. HEALTH EFFECT IMPACT CODES: (B)(4). THE EVENTS OF "SUBSTANTIAL AMOUNT OF FLUID" AND "BREAST IMPLANT-ASSOCIATED ALCL" 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: "SUBSTANTIAL AMOUNT OF FLUID" AND "BREAST IMPLANT-ASSOCIATED ALCL"

    Description of Event or Problem · 0

    THROUGH THE JOURNAL ARTICLE, "CASE REPORT OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA CONFINED BY FIBROUS CAPSULE," HEALTHCARE PROFESSIONAL REPORTED A PATIENT DEVELOPED "LEFT BREAST ENLARGEMENT. MAGNETIC RESONANCE IMAGING INDICATED A SUBSTANTIAL AMOUNT OF FLUID AROUND THE BREAST IMPLANT." CELLS ISOLATED FROM THE FLUID HAD BIOMARKERS "STRONGLY AND DIFFUSELY POSITIVE TO CD30," "WEAK AND FOCALLY POSITIVE TO EMA AND CD3," AND "NEGATIVE TO CYTOKERATIN, S100 PROTEIN, CD7 AND ALK PROTEIN. THESE FINDINGS CONFIRMED THE DIAGNOSIS OF BREAST IMPLANT-ASSOCIATED ALCL." DEVICE WAS EXPLANTED. THE MANUFACTURER OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330223 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Life Threatening