BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 19990290 · Received August 15, 2024

    Report

    Report Number
    19990290
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    MRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH KNOWN INTRA AND EXTRACAPSULAR RUPTURED L BREAST IMPLANT ON MRI. PATIENT SCHEDULED FOR BILATERAL IMPLANT REMOVAL AND BREAST IMPLANT WILL BE SENT BACK TO MANUFACTURER ONCE SHIPPING MATERIAL ARRIVES. ORIGINAL DATE OF IMPLANT PLACEMENT WAS IN 2009. MENTOR RUPTURED SITE MEASURES 6.6 X 2.5CM, 5CM, 5789820, 325CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200483 MENTOR SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS LP 5789820

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female