BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 14286521 · Received May 5, 2022

    Report

    Report Number
    9617229-2022-07053
    Event Type
    Injury
    Date Received
    May 5, 2022
    Report Date
    May 4, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD IS NOT AVAILABLE DUE TO INSUFFICIENT DEVICE DATA. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REPORTED EVENTS OF SEROMA-LATE AND LYMPHADENOPATHY ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE REASON FOR REOPERATION IS: "FLUID RETENTION, AND INFLAMMATION OF THE LYMPH NODS WAS DUE TO A RUPTURE IN MY RIGHT BREAST IMPLANT."

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "PAIN OVER THE PAST 3 WEEKS," "SOURCE OF THE PAIN, FLUID RETENTION, AND INFLAMMATION OF THE LYMPH NODS WAS DUE TO A RUPTURE" PER ULTRASOUND. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463984 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention