BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 22011297 · Received May 13, 2025

    Report

    Report Number
    1645337-2025-05153
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    October 2, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000327
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: PTOSIS. 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 PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE: (RIGHT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504251BC LOT: 9997650 SN: (B)(6) AND (LEFT) 400CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504001BC LOT: 2010568 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268190 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7714096 00081317000327

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention