BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7873211 · Received September 13, 2018

    Report

    Report Number
    1645337-2018-05556
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    May 30, 2018
    Report Date
    August 28, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001393
    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 (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. ADDITIONAL INFORMATION RECEIVED 10/18/2018 INDICATES THE DEVICE WAS A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC, CATALOG NUMBER 3502275, LOT NUMBER 5945802. (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, MENTOR PRODUCT ANALYSIS LAB OBSERVED A CREASE ON THE ANTERIOR VIEW THAT EXTENDED TO THE POSTERIOR VIEW. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. NO OTHER ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS NOT CONFIRMED SINCE NO RENTS WERE FOUND ON THE REPORTED DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE CREASE. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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. THESE FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDERINFLATION OR OVERINFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS CAPSULAR CONTRACTURE OR TOO SMALL A BREAST POCKET, AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES. 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. CONCOMITANT MEDICAL PRODUCTS: SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 300CC, CATALOG NUMBER 3502300. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 300CC BREAST IMPLANT AND EXPERIENCED DEFLATION OF THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT, CATALOG NUMBER 3504251BC, SERIAL NUMBER (B)(4), LOT NUMBER 7511550 ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714236 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5945802 00081317001393

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention