BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT

    MDR report key: 19860118 · Received July 30, 2024

    Report

    Report Number
    19860118
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    October 4, 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 SURGERY. ATAXIA-TELANGIECTASIS MUTATED (ATM) MUTATION SURGERY FOR PROPHYLACTIC BILATERAL MASTECTOMY, AND BILATERAL TISSUE EXPANDERS (MENTOR 450ML WITH INITIAL FILL OF 250ML IN EACH SIDE). PATIENT PRESENTS ON [DATE REMOVED] TO EMERGENCY DEPARTMENT (ED), FOUND TO HAVE LARGE FLUID COLLECTION ON RIGHT CHEST WALL. SURGERY ON [DATE REMOVED] FOR NECROSIS OF MASTECTOMY FLAP AND EXPANDER REMOVAL. ON [DATE REMOVED] PATIENT ADMITTED TO ED, FOUND TO HAVE FLUID ON LEFT CHEST WALL, UNDERWENT IR FOR DRAINAGE AND DRAIN PLACEMENT. ON [DATE REMOVED] TO ED AND ADMITTED, FOUND 11.7 CM FLUID ON LEFT WITH ULTRASOUND. SURGERY ON [DATE REMOVED] WITH FOR INCISION AND DRAINAGE OF BILATERAL BREAST SEROMAS AND PLACEMENT OF 19 FRENCH DRAIN. ON [DATE REMOVED], SURGERY FOR DELAYED INSERTION OF TISSUE EXPANDER RIGHT BREAST (MENTOR 450ML WITH 0 INITIAL FILL). ON [DATE REMOVED] TO ED WITH LEFT BREAST PAIN/REDNESS. ON [DATE REMOVED] BREAST TISSUE EXPANDER REMOVAL BILATERAL. ON [DATE REMOVED ] TO ED FOR PAIN AT JP DRAIN SITE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245082 MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS LP SCPX127MH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other