BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7485633 · Received May 3, 2018

    Report

    Report Number
    1645337-2018-02651
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    April 15, 2018
    Report Date
    April 16, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06/22/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE RECEIVED HAS A DIFFERENT LOT NUMBER FROM THE ONE THAT WAS ORIGINALLY REPORTED. THE PRODUCT RECEIVED LOT IS 5726985. FOLLOW UP IS IN PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 05/18/18, IT WAS REPORTED TO MENTOR THAT THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON 05/18/18, IT WAS REPORTED TO MENTOR THAT THE DATE PROBLEM OBSERVED WAS (B)(6) 2018. THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 295CC ON (B)(6) 2018. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 06/29/18, IT WAS REPORTED TO MENTOR THAT THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. ACCORDING WITH THE INFORMATION RECEIVED FROM THE CUSTOMER TO OBTAIN CLARIFICATION FOR THE WRONG PRODUCT RECEIVED ( LOT #5726985, CATALOG #3501660) AND THE INFORMATION WAS THE SAME AS INITIALLY. SINCE THE REPORTED PRODUCT (LOT # 5760506, CATALOG #3501660) WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF WRONG PRODUCT CLARIFICATION IS RECEIVED AT A LATER DATE, WITHIN THE LAB PRODUCT RETENTION PERIOD, WE WILL PERFORM THE INVESTIGATION AS APPROPRIATE. DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. MENTOR IS AWARE THAT, OVER TIME, SALINE-FILLED IMPLANTS MAY DEFLATE DUE TO FLUID LEAKAGE. CAUSES OF DEFLATION OF SALINE-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA, EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA SUCH AS THAT WHICH CAN OCCUR DURING VIGOROUS EXERCISE, ATHLETICS, MANUAL MASSAGE, AND INTIMATE PHYSICAL CONTACT; STRESS OR TRAUMA TO THE BREAST, MECHANICAL DAMAGE PRIOR TO OR DURING SURGERY, VALVE MALFUNCTIONS OR TISSUE INGROWTH INTO THE VALVE, LEAKAGE FROM THE FILL TUBE, VALVE OR INJECTION DOME (SPECTRUM DEVICES), UNDERFILLING OR OVERFILLING THE IMPLANT (SEE PRODUCT LABEL), DAMAGE FROM SURGICAL INSTRUMENTS, DAMAGE DURING FILL TUBE REMOVAL, DAMAGE DURING THE FILLING STAGE, CLOSED CAPSULOTOMY, SHELL ABRASION, CAPSULAR CONTRACTURE, AND ORIGINS WHICH ARE SIMPLY UNKNOWN. 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. 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: SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 375CC BREAST IMPLANT, SERIAL NUMBER (B)(4), LOT NUMBER 5726985. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 375CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. 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
    325870 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5760506 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other