BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT

    MDR report key: 19860017 · Received July 30, 2024

    Report

    Report Number
    19860017
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    November 10, 2023
    Report Date
    May 23, 2024
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FIVE PATIENTS WITH MENTOR BREAST TISSUE EXPANDERS DEVELOPED INFECTIONS AFTER SURGERYON [DATE REDACTED], PATIENT ADMITTED TO THE OR FOR CARCINOMA OF RIGHT BREAST, ESTROGEN RECEPTOR POSITIVE, BILATERAL MASTECTOMY, AND TISSUE EXPANDER INSERTION (MENTOR 550 ML WITH INITIAL 0 FILL). ON [DATE REDACTED], SURGERY FOR NECROSIS OF THE MASTECTOMY INCISION RIGHT BREAST. ON [DATE REDACTED], REMOVAL OF TISSUE EXPANDER OF RIGHT BREAST. FLUID SENT TO PATH, FOUND TO HAVE PSEUDOMONAS AERUGINOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188378 MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS LP SCPX135MH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other