BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ROUND HIGH PROFILE

    MDR report key: 22197001 · Received June 12, 2025

    Report

    Report Number
    1645337-2025-06496
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    December 14, 2024
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 14-JUN-2025, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: PATIENT INFORMATION (FULL NAME, DOB, RACE, ETHNICITY, AGE AT TIME OF EVENT) WAS PROVIDED. THE PATIENT DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN HER LEFT BREAST. THE PATIENT IS PLANNING ON EXPLANTATION SURGERY IN (B)(6) 2025. THE COUNTRY OF THE EVENT IS AUSTRALIA. THE SUSPECT MEDICAL DEVICE IS A MENTOR MEMORYGEL BREAST IMPLANT 250CC GEL BREAST PROSTHESIS, CATALOG #350-2504BC, LOT #9983048, SERIAL # (B)(6). THE DEVICE WAS MANUFACTURED IN (B)(6) FACILITY. MENTOR MEDICAL SYSTEMS B.V, LOCATED IN LEIDEN, THE NETHERLANDS, IS A FOREIGN MANUFACTURER OF MEDICAL DEVICES THAT ARE NOT CLEARED OR APPROVED FOR SALE IN THE US. IT IS A SEPARATE LEGAL ENTITY FROM MENTOR TEXAS. PER 21 CFR 803.58 AND "MEDICAL DEVICE REPORTING FOR MANUFACTURERS" (FDA GUIDANCE DOCUMENT ISSUED ON NOVEMBER 8, 2016), WE ARE ¿NOT REQUIRED TO SUBMIT MDR REPORTS FOR EVENTS OCCURRING IN OTHER COUNTRIES FOR A DEVICE THAT IS MANUFACTURED IN A FOREIGN COUNTRY AND THAT IS NOT CLEARED OR APPROVED FOR MARKETING IN THE US. HOWEVER, IF MENTOR BECOMES AWARE OF INFORMATION THAT REASONABLY SUGGESTS A DEVICE HAS MALFUNCTIONED AND THAT A SIMILAR DEVICE THAT IS MARKETED IN THE US WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR, THEN MENTOR SHOULD REPORT THE DEVICE MALFUNCTION THAT OCCURRED OUTSIDE THE US." SINCE MENTOR MEDICAL SYSTEMS B.V. DO NOT MARKET ANY DEVICES IN THE US, MANUFACTURE & MARKET ALL THEIR DEVICES OUTSIDE THE US, AND HAVE NEVER HELD FDA APPROVAL NOR CLEARANCE FOR ANY OF THEIR PRODUCTS, THEIR DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTABILITY. AS A RESULT OF THE ABOVE, NO ADDITIONAL MEDWATCH REPORTS WILL BE SUBMITTED FOR THIS COMPLAINT DEVICE. G1 MANUFACTURER CONTACT PHONE NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH UNSPECIFIED MENTOR BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT PATIENT DEVELOPED UNSPECIFIED COMPLICATIONS WHICH MAY REQUIRE IMPLANT REPLACEMENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. THIS MEDWATCH REPORT HAS BEEN DEFAULTED TO GEL BREAST IMPLANT DUE TO UNKNOWN TYPE, AND THE COMMON DEVICE NAME AND PROCODE ARE BEING REPORTED FOR SUBMISSION PURPOSES ONLY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152046 SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 9983048

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other| R