BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7259979 · Received February 9, 2018

    Report

    Report Number
    1645337-2018-00764
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    December 1, 2017
    Report Date
    January 15, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 02/23/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. THE REPLACEMENT PROSTHESES WERE 425CC MENTOR MEMORYGEL BREAST IMPLANTS. (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 MODERATE PROFILE 375CC SALINE PROSTHESIS, CATALOG #3501660, SERIAL #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4)

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION AND ANALYSIS OF THE RETURNED PRODUCT WAS COMPLETED ON 5/10/20018. SUMMARY: IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 375CC PROSTHESIS. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING EXAMINATION, THE PRODUCT EVALUATION TEAM OBSERVED A CREASE ON THE ANTERIOR ASPECT, EXTENDING TO THE POSTERIOR ASPECT. A RENT MEASURING APPROXIMATELY 0.5 CM WAS DISCOVERED WITHIN THE CREASE ON THE POSTERIOR 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. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 375CC PROSTHESIS. IN (B)(6) OF 2017 THE PATIENT SUSPECTED LEAKING DURING EXERTION, WHICH WAS CONFIRMED BY A PHYSICIAN ON (B)(6) 2018. AS A RESULT, THE PATIENT HAD BILATERAL PROSTHESIS REPLACEMENT WITH SILICONE IMPLANTS ON (B)(6) 2018. NO OTHER ADVERSE EVENTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103632 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5594971 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention