BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR 350-1880M

    MDR report key: 21546597 · Received March 7, 2025

    Report

    Report Number
    21546597
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 18, 2025
    Manufacturer
    MENTOR TEXAS LP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    10-YEAR-OLD ENCAPSULATED MENTOR SALINE BREAST IMPLANTS REMOVED - LT [LEFT] HAD BROWN LIQUID/ RT [RIGHT] WITH FUNGAL LOOKING BALL INSIDE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437238 MENTOR 350-1880M PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS LP. 350-1880M

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female