BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7401552 · Received April 5, 2018

    Report

    Report Number
    1645337-2018-02093
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    January 1, 2015
    Report Date
    March 8, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001393
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESIS, CATALOG #3502300, SERIAL #(B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 6733859 WAS REVIEWED ON 4/18/2018 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESES ON (B)(6) 2013. IN 2015 THE PATIENT NOTED BILATERAL RIPPLES, AIR POCKETS, AND DEFLATION. IN 2017, THESE ISSUES WERE CONFIRMED BY A PHYSICIAN¿S EXAMINATION. ADDITIONALLY, WORSENING BACK PAIN, BREAST PAIN, BRAIN FOG, AND FATIGUE WERE ALSO REPORTED. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2018. (SEE 1645337-2018-02092 FOR CONTRALATERAL PROSTHESIS REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241867 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6733859 00081317001393

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention