BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 23248072 · Received October 8, 2025

    Report

    Report Number
    1645337-2025-11224
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    July 8, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 05, 2025, A PHOTO EVALUATION FOR THE DEVICE WAS COMPLETED. PHOTO EVALUATION SUMMARY: UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, THE IMPLANT WAS OBSERVED RUPTURED. AS THE PRODUCT INVOLVED IN THIS COMPLAINT WAS DISCARDED, THE DEVICE COULD NOT BE ANALYZED ACCORDING TO OUR PROCEDURES. MENTOR ALSO PERFORMED A MANUFACTURING RECORD EVALUATION RELATED TO THE REPORTED COMPLAINT FOR THE FINISHED DEVICE LOT NUMBER. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED AS PART OF THIS EVALUATION. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. 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: RUPTURE. 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 400CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3504001BC) WITH LOT NUMBER 9991228.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584329 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7410630

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention