BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL BOOST BREAST IMPLANT 260CC

    MDR report key: 18491401 · Received January 11, 2024

    Report

    Report Number
    18491401
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 19, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT (B)(6) RIGHT MASTECTOMY REQUIRED IMPLANT. MENTOR MEMORYGEL BOOST BREAST IMPLANT 260CC HAD DEFECT AND AIR BUBBLE. IMPLANT ON OR FIELD AND PROMPTLY REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638870 MENTOR MEMORYGEL BOOST BREAST IMPLANT 260CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS LP SHPB-260 9914704

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown