BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 24717983 · Received March 30, 2026

    Report

    Report Number
    1645337-2026-03548
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 2, 2026
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001225
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON APR 13, 2026, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE IMPACTED PRODUCT LOT NUMBER WAS IDENTIFIED AS 2130232. 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. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND NO LEAK SITES WERE DETECTED DURING THE ANALYSIS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE BREAST IMPLANT WAS RETURNED WITHOUT DETECTABLE DAMAGE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90688 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 2130232 00081317001225

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention