BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7759904 · Received August 7, 2018

    Report

    Report Number
    1645337-2018-04689
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    February 1, 2018
    Report Date
    July 12, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001201
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/10/2018, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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: RIGHT MENTOR SMOOTH ROUND MODERATE PROFILE 200CC SALINE BREAST IMPLANTS, CATALOG NUMBER 3501625, LOT NUMBER 133622. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SALINE IMPLANTS ON (B)(6)1996 EXPERIENCED BILATERAL DEFLATION THAT WAS OBSERVED IN FEBRUARY 2018. THE PATIENT REPORTED PAIN IN THE RIGHT BREAST. THE DEVICES REMAIN IMPLANTED. PER PATIENT, THE PHYSICIAN OBSERVED MOLD ON THE VALVE OF THE IMPLANT. NO DETAILS WERE PROVIDED ON HOW THE MOLD WAS OBSERVED AND IF THE ISSUE WAS BILATERAL OR UNILATERAL. THE CUSTOMER REQUESTED THAT NO FURTHER CONTACT BE INITIATED FOR FOLLOW UP ATTEMPTS. THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599540 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 116684 00081317001201

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other