BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 20950474 · Received December 17, 2024

    Report

    Report Number
    9617229-2024-26320
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 17, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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: CAPSULAR CONTRACTURE BAKER GRADE IV, RUPTURE, SEROMA, AND LYMPHADENOPATHY.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, SUDDEN SEVERE PAIN, INCREASE IN LOCAL TEMPERATURE AND SLIGHT SKIN HYPEREMIA, RIPPLING, LIQUID CONTENT, PRESENCE OF INTRAMAMMARY LYMPH NODE IN QSE. PATIENT LATER REPORTED CYSTS AND "LOCAL INFLAMMATORY/REACTIVE PROCESS". PATIENT LATER REPORTED "UNABLE TO WORK, DRIVE OR CARRY OUT THE TRAINING ROUTINE BECAUSE OF THE PAIN." DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438114 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention