BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7576376 · Received June 6, 2018

    Report

    Report Number
    1645337-2018-03533
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 18, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001386
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 6/7/2018, 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. ON 6/28/2018, MENTOR RECEIVED ADDITIONAL INFORMATION: DATE OF EXPLANT: (B)(6) 2018, IS REQUIRED INTERVENTION: CHECK. THE PATIENT ELECTED TO UNDERGO BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE PROSTHESES ON (B)(6) 2018. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS ALSO INDICATED. SEE MANUFACTURER REPORT NUMBER 1645337-2018-03966 FOR THE LEFT BREAST PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7/6/2018. DEVICE EVALUATION SUMMARY: 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 MEASURING APPROXIMATELY 0.1 CM WITHIN A CREASE ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. 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. THE DHR WAS REVIEWED 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. 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

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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: LEFT MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC SALINE PROSTHESIS, CATALOG: 3502275, SERIAL NUMBER: (B)(4), LOT: 5914051. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC SALINE PROSTHESIS. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418110 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5914051 00081317001386

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention