BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7524037 · Received May 17, 2018

    Report

    Report Number
    1645337-2018-02998
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    April 20, 2018
    Report Date
    April 24, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001423
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/7/2018, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AS WELL AS ADDITIONAL INFORMATION REGARDING THIS EVENT. ON 5/11/2018, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT. THE EVENT DATE HAS ALSO BEEN UPDATED TO (B)(6) 2018. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. UPON INITIAL INSPECTION, NO ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED ACCORDING TO MENTOR PROCEDURES, AND IT REVEALED A RENT MEASURING APPROXIMATELY 0.3 CM ON THE ANTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT REVEALED PARALLEL STRIATIONS. NO OTHER ANOMALIES WERE FOUND. THE COMPLAINT WAS CONFIRMED SINCE A RENT WAS FOUND IN THE DEVICE. THE TYPE OF STRIATIONS OBSERVED DURING MICROSCOPIC ANALYSIS ARE MORE INDICATIVE OF SHARP INSTRUMENT DAMAGE RATHER THAN SHELL FAILURE DUE TO WEAR. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5891066 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. 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 THEIR USE AS OUTLINED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/18/2018, 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 · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE, CATALOG #3502375, LOT #5825999 SN #(B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS DETERMINED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365833 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5891066 00081317001423

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other