BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8669068 · Received June 4, 2019

    Report

    Report Number
    1645337-2019-13241
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 10, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001768
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 6/18/02019. THE DEVICE WAS DISCARDED AND WAS EXPLANTED ON (B)(6) 2019. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 2. IS OTHER SERIOUS- UNCHECK 2. IS REQUIRED INTERVENTION- CHECK A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 85854, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. 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 MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NO EXPLANT OR REOPERATION WAS PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION HAS NOT BEEN DIAGNOSED BY A PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460226 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 85854 00081317001768

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R