BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 19680666 · Received July 5, 2024

    Report

    Report Number
    1645337-2024-08005
    Event Type
    Injury
    Date Received
    July 5, 2024
    Date of Event
    June 3, 2024
    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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 01, 2024, 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. ON AUGUST 12, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION REPORTING THAT THE INCORRECT IMPACTED DEVICE WAS PREVIOUSLY REPORTED. IT WAS REPORTED THAT THE "DEFLATED" DEVICE HAD SERIAL NUMBER (B)(6). THE CORRECT IMPACTED DEVICE INFORMATION WAS UPDATED IN SECTION D OF THIS REPORT. THE DEVICE LOT NUMBER HAS BEEN UPDATED TO 9780467. 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. THE PATIENT'S REPLACED THE IMPACTED DEVICE WITH A MENTOR BREAST PROSTHESIS WITH LOT NUMBER 9977712. 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: ANISOMASTIA/SQUISHY IMPLANT. 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).

    Additional Manufacturer Narrative · 0

    ON AUGUST 30, 2024, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE, DETERMINED THAT THE SAL SMOOTH RND DIAP 325CC BREAST IMPLANT WAS FOUND TO BE DEFLATED. A TEAR WAS OBSERVED MEASURING APPROXIMATELY 2.0CM ON THE ANTERIOR VIEW. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE TEAR, AND PARALLEL STRIATIONS WERE FOUND IN AN AREA OF THE TEAR, MEASURING APPROXIMATELY 0.2 CM. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 20-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND MENTIONED THAT THE BREAST PROSTHESIS FELT ¿SQUISHY¿ POST-OPERATIVELY, WHICH WAS DIAGNOSED BY THE SURGEON AT THE TIME OF CONSULTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977987 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 9780467 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Required Intervention