BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7924816 · Received October 1, 2018

    Report

    Report Number
    1645337-2018-05918
    Event Type
    Injury
    Date Received
    October 1, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 10, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 10/2/2018, 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 (B)(6) 2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. IT WAS INITIALLY REPORTED THAT THE CONCOMITANT PRODUCT IS A MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESIS, CATALOG #3501650, LOT #220832. NEW INFORMATION STATES IT IS A MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESIS, CATALOG #3501660, LOT #172021. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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 PROFILE 325CC SALINE BREAST PROSTHESIS, CATALOG #3501650, LOT #220832. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESIS THAT DEFLATION AFTER IMPLANTATION. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A DOCTOR. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764311 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 172021 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention