BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7806928 · Received August 22, 2018

    Report

    Report Number
    1645337-2018-05116
    Event Type
    Injury
    Date Received
    August 22, 2018
    Report Date
    August 16, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001423
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/22/2018, THE DEVICE HISTORY RECORD (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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PRODUCT EVALUATION TEAM DISCOVERED A CREASE RUNNING FROM THE ANTERIOR ASPECT TO THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. SOME BREAST PTOSIS IS A NORMAL COMPONENT OF THE MATURE BREAST. AUGMENTATION ALONE, WITHOUT CONSIDERATION OF THE PTOSIS CAN PRODUCE A LESS THAN DESIRABLE COSMETIC RESULT KNOWN AS A "ROCK IN SOCK" DEFORMITY OR AN INCREASED PTOTIC APPEARANCE. SOME BREAST PTOSIS IS A NORMAL COMPONENT OF THE MATURE BREAST. PTOSIS IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. 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 450CC SALINE BREAST IMPLANT, CATALOG NUMBER 3502375, LOT NUMBER 5912717, SERIAL NUMBER (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED, AND THERE WAS ISSUE BILATERALLY WITH PTOSIS AFTER IMPLANTATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: RIGHT REPLACED WITH CATALOG NUMBER 3502375, LOT NUMBER 7552145, AND LEFT REPLACED WITH CATALOG NUMBER 3502375, LOT NUMBER 7550093, AND SERIAL NUMBER (B)(4) ON (B)(6) 2018. THIS REPORT IS FOR THE LEFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648947 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5881882 00081317001423

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention