BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 11116812 · Received January 5, 2021

    Report

    Report Number
    9617229-2020-22432
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, THIS REPORT IS A DUPLICATE OF MRN 2024601-2011-00664. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER MRN 2024601-2011-00664.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW, THIS REPORT IS A DUPLICATE OF MRN 2024601-2011-00664. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER MRN 2024601-2011-00664.

    Additional Manufacturer Narrative · 1

    THE EVENTS OF LYMPHOMA-ALCL-SUSPECTED 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: LYMPHOMA-ALCL-SUSPECTED AND LUMP/NODULE. 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.

    Description of Event or Problem · 1

    THROUGH THE JOURNAL ARTICLE "FAT GRAFTING AFTER IMPLANT REMOVAL DUE TO ANAPLASTIC LARGE CELL LYMPHOMA MAY MIMIC RECURRENCE" IT WAS REPORTED A PATIENT DIAGNOSED WITH BIA-ALCL. BIA-ALCL MARKERS NOT PROVIDED. THE PATIENT PRESENTED WITH ¿NODULE¿ AND WAS TREATED WITH ¿IMPLANT REMOVAL AND CHEMOTHERAPY¿. 2 WEEKS LATER A RELAPSE IS REPORTED. THE AFFECTED SIDE HAS NOT BEEN PROVIDED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12527 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention