BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7526558 · Received May 18, 2018

    Report

    Report Number
    1645337-2018-03020
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 24, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001379
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING EXAMINATION, THE PRODUCT EVALUATION TEAM (PE) OBSERVED A CREASE ON THE ANTERIOR ASPECT. A RENT MEASURING APPROXIMATELY 6 CM WAS DISCOVERED WITHIN THE CREASE ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE FOUND. THE COMPLAINT WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE, NOR THE ORIGIN OF WHITE MATERIAL OBSERVED IN THE DEVICE. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 6484167 HAS BEEN REVIEWED, AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. ALL IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED TO THE MANUFACTURING PROCESS. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES, AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE MANUFACTURING AND EXPIRATION DATES WERE MISTAKENLY OMITTED FROM THE OTHER SUPPLEMENTAL REPORT SUBMITTED ON 6/22/2018. 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: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 225CC SALINE, CATALOG #3502225, LOT #5901573. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH (RIGHT) MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC AND (LEFT) MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 225CC SALINE BREAST PROSTHESES. RIGHT BREAST PROSTHESIS DEFLATION WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369428 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6484167 00081317001379

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention