BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 25050113 · Received April 30, 2026

    Report

    Report Number
    1645337-2026-05056
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 19, 2026
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    10081317027802
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 CONTRACTURES GRADE III. 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

    A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE UTILIZING MENTOR MEMORYGEL, XTRA 255CC SILICONE PROSTHESIS. POSTOPERATIVELY, SHE EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURES GRADE III. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENTS PER FOLLOWING: L: 2083794-053 / SMHX-25, ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201314 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 8460973 10081317027802

    Patients

    Seq Age Sex Outcome Treatment
    1