BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 18526823 · Received January 17, 2024

    Report

    Report Number
    9617229-2024-00988
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    September 19, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: RICO SAYETZI, CERDA FELIP, CORONA RAFAEL, MIRANDA JORGE, MORENO SERGIO, RICO ENRIQUE, SÁNCHEZ BENITO, AMERICAN JOURNAL OF HEMATOLOGY STUDY LLM ABSTRACTS SUPPLEMENT, 10 SEPTEMBER 2023, S36 THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: LYMPHOMA-ALCL, AND SEROMA.

    Description of Event or Problem · 0

    THROUGH ARTICLE JOURNAL AMERICAN JOURNAL OF HEMATOLOGY STUDY, HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "ASYMMETRY OF BREASTS", "PERIPROSTHETIC FLUID" AND "BIA-ALCL IN RIGHT PERIPROSTHETIC CAPSULE". HISTOPATHOLOGICAL MARKERS ARE REPORTED AND SPECIFIC (CD30 POSITIVE AND ALK NEGATIVE). DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405483 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention