BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7259826 · Received February 9, 2018

    Report

    Report Number
    1645337-2018-00797
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    November 1, 2017
    Report Date
    January 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/20/2018, 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. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. DURING EXAMINATION, THE PRODUCT EVALUATION TEAM (PE) OBSERVED CREASES ON BOTH ASPECTS. LEAK TESTING WAS PERFORMED ACCORDING TO MENTOR PROCEDURES, AND A RENT MEASURING APPROXIMATELY 0.1 CM WITHIN A CREASE ON THE ANTERIOR ASPECT WAS REVEALED. NO OTHER ANOMALIES WERE FOUND. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE, NOR THE ORIGIN OF WHITE MATERIAL OBSERVED IN THE DEVICE. ALL IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED TO THE MANUFACTURING PROCESS. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES, AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/4/2018, MENTOR RECEIVED INFORMATION THAT IDENTIFIED INITIALLY REPORTED UNKNOWN DEVICE: BRAND NAME: MENTOR SMOOTH ROUND MODERATE PROFILE PROCODE: FWM. COMMON NAME: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE. CATALOG: 3501650, LOT: 5574615, UNIQUE IDENTIFIER( UDI): (B)(4), PMA/ 510(K): P990075. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, THE MENTOR FAILURE ANALYSIS LAB 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNKNOWN MENTOR SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE IMPLANTS ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102088 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5574615

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention