BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 11117673 · Received January 5, 2021

    Report

    Report Number
    9617229-2020-22862
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    August 21, 2019
    Report Date
    January 5, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: FAT GRAFTING AFTER IMPLANT REMOVAL DUE TO ANAPLASTIC LARGE CELL LYMPHOMA MAY MIMIC RECURRENCE. NIR BITTERMAN MD, PAULA SIMOVIZ MD, TAMAR TADMOR MD, LIHI TZUR MD, NOAM CALDERON MD, AND OHAD BEN-NUN MD. IMAJ ¿VOL21¿ AUGUST2019. THE REPORTED EVENTS 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: SEROMA AND LYMPHOMA-ALCL.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: "FAT GRAFTING AFTER IMPLANT REMOVAL DUE TO ANAPLASTIC LARGE CELL LYMPHOMA MAY MIMIC RECURRENCE.". THE ARTICLE REPORTS A PATIENT DIAGNOSED WITH BIA-ALCL. THE PATIENT PRESENTED WITH ¿SEROMA¿ AND WAS TREATED WITH ¿CAPSULECTOMY AND DEVICE REMOVAL ¿. 2 MONTHS LATER A RELAPSE IS REPORTED PRESENTING WITH " AXILLARY. SUPRACLAVICULAR, AND MEDIASTINAL LYMPH NODE INVOLVEMENT AND BILATERAL PLEURAL EFFUSIONS WITH LUNG INFILTRATES". THE AFFECTED SIDE AND BIOMARKERS HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12574 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention