BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 8112254 · Received November 28, 2018

    Report

    Report Number
    1645337-2018-07085
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    August 1, 2018
    Report Date
    November 1, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001645
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SMOOTH ROUND HIGH PROFILE 330CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE XTRA GEL, 535 CC GEL IMPLANTS ON (B)(6) 2018. THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, THE MENTOR PRODUCT ANALYSIS LAB OBSERVED A CREASE ON THE POSTERIOR VIEW THAT EXTENDED TO THE ANTERIOR VIEW. A LINE OF SHELL ABRASION WAS OBSERVED WITHIN THE CREASE ON THE POSTERIOR ORIENTATION TAB, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. A RENT WAS DISCOVERED WITHIN THE SHELL ABRASION MEASURING APPROXIMATELY 0.2 CM. NO OTHER 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. THE MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE RENT, CREASE AND SHELL ABRASION OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION 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 OR THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. 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. 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. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND HIGH PROFILE 330CC SALINE BREAST IMPLANT, CATALOG # 3503330, LOT # 5990873. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SMOOTH ROUND HIGH PROFILE 330CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE XTRA GEL, 535 CC GEL IMPLANTS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952808 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6409551 00081317001645

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention