BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7511786 · Received May 14, 2018

    Report

    Report Number
    1645337-2018-02861
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    March 1, 2018
    Report Date
    April 25, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001249
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE PROSTHESES ON (B)(6) 2018. THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. THE PRODUCT EVALUATION TEAM DISCOVERED A RENT AT THE VALVE. NO OTHER ANOMALIES WERE DISCOVERED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, THE PRODUCT EVALUATION TEAM WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE WHITE MATERIAL FOUND ON THE DEVICE. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: RIGHT MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE PROSTHESIS, CATALOG: 3501645, LOT: 223299. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 5/22/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 5/18/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353770 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 223299 00081317001249

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention