BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 19187823 · Received April 25, 2024

    Report

    Report Number
    9617229-2024-07243
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    September 15, 2022
    Report Date
    September 16, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT DIAGNOSED WITH BIA-ALCL, HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- PROVIDED. CLARIFICATION D.1 BRAND NAME: UNKNOWN MANUFACTURER, DEFAULT UNKNOWN MAMMARY IMPLANT. JOURNAL ARTICLE CITATION: DAVANZO, V.; FALDA, A.; FOGAR, P.; LUDWIG, K.; ZUIN, J.; TOFFANIN, M.C.; PIZZI, M.; DEI TOS, A.P.; BASSO, D. FLOW CYTOMETRY ANALYSIS IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: THREE CASE REPORTS. INT. J. MOL. SCI. 2024, 25, 3518. HTTPS://DOI.ORG/10.3390/IJMS25063518 ACADEMIC EDITORS: CLAUDIO ORTOLANI, JOSÉ-ENRIQUE O¿CONNOR AND MONIA LENZI. RECEIVED: 19 FEBRUARY 2024, REVISED: 16 MARCH 2024, ACCEPTED: 18 MARCH 2024, PUBLISHED: 20 MARCH 2024. CONTRIBUTING AUTHORS: VERONICA DAVANZO LABORATORY MEDICINE UNIT, BIOMEDICAL SCIENCES DEPARTMENT¿DSB, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY ALESSANDRA FALDA: AUTHOR FOR CORRESPONDENCE; EMAIL: [email protected] LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY PAOLA FOGAR LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY KATHRIN LUDWIG SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY JENNY ZUIN LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY MARIA CRISTINA TOFFANIN DEPARTMENT OF BREAST SURGERY, VENETO INSTITUTE OF ONCOLOGY IOV IRCCS, 35128 PADOVA, ITALY MARCO PIZZI SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY ANGELO PAOLO DEI TOS SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY DANIELA BASSO LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY LABORATORY MEDICINE UNIT, DEPARTMENT OF MEDICINE¿DIMED, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY THE EVENTS OF SEROMA-LATE AND LYMPHOMA-ALCL ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: SEROMA-LATE, LYMPHOMA-ALCL.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6A, D6B, H6.

    Description of Event or Problem · 0

    A LITERATURE REVIEW TITLED "FLOW CYTOMETRY ANALYSIS IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: THREE CASE REPORTS" REPORTED FOR CASE 3 ON RIGHT SIDE: PERIPROSTHETIC EFFUSION, DIAGNOSIS OF BIA-ALCL, BIOMARKERS COMPLETELY REPORTED. HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- CONFIRMED. STATUS OF DEVICE IS UNKNOWN. MANUFACTURER OF DEVICE IS UNKNOWN.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541904 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening