BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7469048 · Received April 27, 2018

    Report

    Report Number
    1645337-2018-02492
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    March 28, 2018
    Report Date
    March 30, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001386
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    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 PLUS PROFILE 275CC SALINE, CATALOG #3502275, LOT #6509638, SN # (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/7/2018, MENTOR BECAME AWARE THAT THE CORRECT EXPLANTATION DATE WAS (B)(6) 2018. ON 5/23/2018, MENTOR ALSO BECAME AWARE THAT THERE WAS ALSO CAPSULAR CONTRACTURE ON THE CONCOMITANT PRODUCT (RIGHT BREAST). AS A RESULT OF THE LEFT BREAST PROSTHESIS DEFLATION AND THE RIGHT BREAST CAPSULAR CONTRACTURE, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH (LEFT) MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL CATALOG #3503254BC LOT #7566026 SN #(B)(4) AND (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL CATALOG #3503254BC LOT #6802154 SN #(B)(4) ON (B)(6) 2018. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 6/12/2018, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. UPON INITIAL INSPECTION, THE DEVICE APPEARS INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE DISCOVERED. COMPLAINT WAS NOT CONFIRMED. 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) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC SALINE BREAST PROSTHESES. LEFT BREAST PROSTHESIS WAS REPORTED TO HAVE LEAKED, WAS SOFTER AND FLATTER. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312667 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6509638 00081317001386

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention