BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 17916412 · Received October 11, 2023

    Report

    Report Number
    1645337-2023-12113
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    September 20, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 09, 2023, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. IT WAS REPORTED THAT THE DEVICE DATE OF EXPLANTATION WAS ON (B)(6) 2023. SECTION D6B. HAS BEEN UPDATED TO REFLECT THIS ADDITIONAL INFORMATION. ON NOVEMBER 10, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. IT WAS REPORTED THAT THE SIDE OF THE DEFLATION WAS ON THE PATIENT'S RIGHT SIDE. THE DEVICE LOT NUMBER WAS UPDATED FROM 6869620 TO 6953394. THE DEVICE SERIAL NUMBER WAS UPDATED FROM (B)(6) TO (B)(6). A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR LOT NUMBER 6953394, 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. ON NOVEMBER 14, 2023, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 325CC BREAST IMPLANT HAD A CREASE/FOLD ON THE POSTERIOR VIEW. IN ADDITION, A TEAR WAS NOTICED WITHIN THE CREASE/FOLD, MEASURING APPROXIMATELY 0.1 CM. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE WAS CONSISTENT WITH NORMAL WEAR. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. 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: DEFLATION. SECTION D6B. EXPLANTATION DATE: (B)(6) 2023. 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 34-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115014 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6953394 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention