BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 22143009 · Received June 4, 2025

    Report

    Report Number
    1645337-2025-06156
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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. LOT 9991137: MANUFACTURING DATE: MAY/29/2024 EXPIRATION DATE: MAY/23/2029. 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. LOT 9992276: MANUFACTURING DATE: JUN/17/2024 EXPIRATION DATE: JUN/16/2029 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: NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE HAS BEEN RECEIVED. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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 CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO UNSPECIFIED GEL BREAST PROSTHESES AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON ONE SIDE AND DEVICE MIGRATION ON ANOTHER SIDE POST-OPERATIVELY. THE PATIENT REPORTED THAT ¿ONE IS REALLY HARD AND DOESN¿T LOOK RIGHT, AND THE OTHER BOTTOMED OUT AND DROPPED.¿ AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT DID NOT SPECIFY WHICH SIDES PERTAINED TO EACH AFFECTED SIDE. FOLLOW UP ATTEMPTS ARE CURRENTLY ONGOING TO CLARIFY THE EVENT TO EACH AFFECTED SIDE. IF MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THIS REPORT IS FOR THE B SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626243 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9992276/9991137

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other