BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8190819 · Received December 21, 2018

    Report

    Report Number
    1645337-2018-07515
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    October 20, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001416
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL IMPLANTS, CATALOG # 3504504BC, S/NS (B)(4) ON (B)(6) 2018. THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. THE MENTOR PRODUCT ANALYSIS LAB¿S VISUAL EXAMINATION INDICATED THE DEVICE APPEARS INTACT AND NO ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. 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. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5920584 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. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL IMPLANTS, CATALOG # 3504504BC, S/NS (B)(4) (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029423 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5920584 00081317001416

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention