BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 18976102 · Received March 25, 2024

    Report

    Report Number
    9617229-2024-05108
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    January 1, 2022
    Report Date
    March 25, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF SEROMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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-LATE.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE PAIN, BURNING NIPPLE, RECALL, SEROMA, "COMPLEX CYST", AND ISOECHOIC NODULAR IMAGE, WITH REGULAR CONTOURS IN QUANTITATIVE SUSCEPTIBILITY MAPPING (QSM). PATIENT ALSO REPORTED "LABYRINTHITIS AND HIGH BLOOD PRESSURE" WHICH ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11035 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention