BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 16013766 · Received December 20, 2022

    Report

    Report Number
    16013766
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 5, 2022
    Manufacturer
    MENTOR TEXAS L.P.
    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 IN FOR CAPSULAR CONTRACTION OF BREAST IMPLANT ON [REDACTED DATE]. IMPLANTS ORIGINALLY PLACED ON [REDACTED DATE]. IMPLANTS SENT TO PATHOLOGY; RECEIVED RIGHT AND LEFT BREAST IMPLANTS RIGHT IMPLANT 268G 9.5X9.5X5CM THE WALL IS SMOOTH, CLEAR, COLORLESS AND GLISTENING. THE WALL DISPLAYS THE INSCRIPTION "MENTOR, 9610063, HPX 260 CC." THE LUMEN CONTAINS CLEAR, COLORLESS GELATINOUS MATERIAL. THE LEFT IMPLANT IS 265G, 9.5 X 9.5 X 5.0 CM. THE WALL IS SMOOTH, CLEAR, COLORLESS, AND GLISTENING. THE WALL DISPLAYS THE INSCRIPTION "MENTOR, 9610063, HPX 260 CC." THE LUMEN CONTAINS CLEAR, COLORLESS GELATINOUS MATERIAL. THERE ARE NO ATTACHED SOFT TISSUES. PER MD NOTES, SPECIMENS ARE TO BE RETURNED TO MANUFACTURER FOR REIMBURSEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2915147 MENTOR SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS L.P. 9610063

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Female