BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 17877520 · Received October 5, 2023

    Report

    Report Number
    1645337-2023-11824
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    August 28, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001317
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED ON OCTOBER 26, 2023, STATED THAT THE PATIENT ALSO EXPERIENCED BILATERAL DEVICE MIGRATION. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULORRHAPHY WITH BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT: 3052500, SN: (B)(6), R/CAT: 3052500, SN: (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON JUNE 15, 2024: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 575CC BREAST IMPLANT HAD AN AREA OF SHELL ABRASION ON THE ANTERIOR VIEW. LEAK TESTING WAS PERFORMED, ACCORDING TO MENTOR PROCEDURE, AND IT IDENTIFIED A TEAR WITHIN THE SHELL ABRASION MEASURING APPROXIMATELY 0.1 CM. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE DEFLATION IS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE CONTINUOUS AND SUSTAINED STRESSES ON THE DEVICE. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. 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 FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND MODERATE PROFILE, 575CC SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS CONFIRMED THROUGH IMAGING. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNSPECIFIED PROSTHESIS ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276941 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 00081317001317

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention