BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODERATE PLUS

    MDR report key: 19556519 · Received June 18, 2024

    Report

    Report Number
    19556519
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 21, 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 SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL ON [REDACTED DATE]. PATIENT HAS INITIAL SURGERY SERVAL YEARS AGO WITH ANOTHER PHYSICIAN AND DEVELOPED GRADE 3 CAPSULAR CONTRACTURE ON THE LEFT SIDE WITH LEFT SIDED ASYMMETRY AND PTOSIS ON THE RIGHT BREAST PARENCHYMA. PATIENT INITIATED A WARRANTY WITH MENTOR WORLDWIDE AND THE IMPLANTS WILL BE RETURNED TO THE MANUFACTURER AFTER THIS REPORT SUBMISSION. PATHOLOGY- RECEIVED BREAST LEFT IMPLANT MEASURING 13.3X13.3X2.8CM WITH THE LEGIBLE INSCRIPTION: MENTOR: 9764234 M+ 400CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072079 MODERATE PLUS SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS LP 9764234

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female