BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7347263 · Received March 16, 2018

    Report

    Report Number
    1645337-2018-01582
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 16, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001409
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 6/27/2018. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESIS. ON (B)(6) 2018 DEFLATION WAS DIAGNOSED BY A PHYSICAL EXAMINATION. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. THE PRODUCT EVALUATION TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 0.3 CM WITHIN A CREASE ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, THE PRODUCT EVALUATION TEAM WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. 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. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE THE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 5893912 WAS REVIEWED ON 4/11/2018 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

    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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESIS, CATALOG #3502325, SERIAL # (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESIS. ON (B)(6) 2018 DEFLATION WAS DIAGNOSED BY A PHYSICAL EXAMINATION. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESES WAS PERFORMED ON (B)(6) 2018. THE RIGHT SIDE WAS INFLATED TO 360CCS, AND LEFT WAS INFLATED TO 350CCS. THERE WERE NO ADDITIONAL ISSUES NOTED. THE PATIENT WAS RECOVERED AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188772 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5893912 00081317001409

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention