BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8081804 · Received November 16, 2018

    Report

    Report Number
    1645337-2018-06893
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    September 15, 2018
    Report Date
    November 1, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001317
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12/07/2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. IT WAS INITIALLY REPORTED THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE BREAST PROSTHESIS, CATALOG #3501690, LOT #5591004, SERIAL #(B)(4), UDI # (B)(4). NEW INFORMATION STATES THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 600CC SALINE BREAST PROSTHESIS, CATALOG #3502600 LOT #5950150, SERIAL # UNKNOWN, UDI #(B)(4). ON 12/12/2018, THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5950150 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. ON 12/13/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. 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. AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE MATERIAL OBSERVED. ACCORDING TO THE INFORMATION PROVIDED, MENTOR PRODUCT ANALYSIS LAB CONCLUDED THE CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST WAS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. (B)(4).

    Additional Manufacturer Narrative · 0

    ON 11/17/2018, 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. ON 11/26/2018, THE MENTOR PRODUCT ANALYSIS LAB 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. ON 11/26/2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. PATIENT HAD EXPLANTED DEVICES REPLACED WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC SALINE BREAST PROSTHESES.

    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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE NATIVE AMERICAN PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 525CC SALINE BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE LEFT BREAST PROSTHESIS DEFLATED AFTER IMPLANTATION. THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND EXPERIENCED TRAUMA TO HER BREASTS. IN ADDITION, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE II-II) IN HER RIGHT BREAST. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918489 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5950150 00081317001317

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention