BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORY GEL RESTERILIZABLE GEL SIZER ULTRA-HIGH PROFILE 375 CC

    MDR report key: 18491483 · Received January 11, 2024

    Report

    Report Number
    18491483
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    November 16, 2023
    Report Date
    November 16, 2023
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    MRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DR REQUESTED A BREAST IMPLANT SIZER MENTOR MEMORY GEL RESTERILIZABLE GEL SIZER ULTRA-HIGH PROFILE 375CC WAS CHOSEN TO BE PLACED IN RIGHT BREAST OF PATIENT. REF# RSZ-5375S, LOT# 6725847. ONCE OPENED AND HANDED OFF TO STERILE FIELD, IMPLANT WAS INSPECTED AND CHECKED FOR STERILITY. AS SURGEON WAS PLACING SIZER INTO PATIENT'S RIGHT BREAST CAVITY IT RUPTURED IN HIS HANDS, AT WHICH TIME SURGEON QUICKLY REMOVED IT AND IT WAS TAKEN OFF THE FIELD. ALL GLOVES WERE CHANGED PATIENT'S RIGHT BREAST CAVITY WAS IRRIGATED WITH BETADINE AND INSPECTED; PROCEDURE CONTINUED WITHOUT INCIDENT. MANUFACTURER RESPONSE FOR BREAST IMPLANT SIZER, MENTOR MEMORY GEL RESTERILIZABLE GEL SIZER ULTRA-HIGH PROFILE 375CC (PER SITE REPORTER), CLINICAL SITE NOTIFIED THE MFG DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003417 MENTOR MEMORY GEL RESTERILIZABLE GEL SIZER ULTRA-HIGH PROFILE 375 CC SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS LP RSZ5375S 6725847

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown