BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7862523 · Received September 10, 2018

    Report

    Report Number
    1645337-2018-05480
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    June 1, 2016
    Report Date
    August 15, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001409
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: RIGHT MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, CATALOG NUMBER 3502325, SERIAL NUMBER (B)(4), LOT NUMBER 6961169. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESES IMPLANTATION WITH MENTOR SALINE IMPLANTS ON (B)(6) 2015 DEVELOPED BILATERAL SHARP PAIN DOWN THE SIDES OF BOTH BREASTS THAT BEGAN IN (B)(6) 2016. THE PATIENT ALSO REPORTED THAT SHE HAS AN AUTOIMMUNE DISEASE. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018. NO OTHER CASE DETAILS WERE PROVIDED. THIS REPORT IS FOR THE LEFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703128 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6885986 00081317001409

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention