BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 20252264 · Received September 18, 2024

    Report

    Report Number
    1645337-2024-10921
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    July 24, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001676
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 40-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED MILD CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3507004BC) WITH LOT NUMBER 9992367.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531875 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6839406 00081317001676

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention