BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE 300CC

    MDR report key: 8649452 · Received May 29, 2019

    Report

    Report Number
    1645337-2019-12759
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    April 9, 2019
    Report Date
    April 30, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001249
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON 6/24/2019: DURING EVALUATION OF THE SAMPLE A CREASE WAS OBSERVED IN THE POSTERIOR VIEW. LEAK TESTING WAS PERFORMED AND IT REVEALED A TEAR WITHIN CREASE, MEASURING APPROXIMATELY LESS THAN 0.1 CM . NO OTHER ANOMALIES WERE OBSERVED. THESE KIND OF 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 SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. 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 MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. CONCOMITANT MEDICAL PRODUCTS: RIGHT-MENTOR SMOOTH ROUND MODERATE PROFILE, CATALOG NUMBER 3501645 LOT NUMBER 233713. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 300CC, WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS NOTICED BY THE PATIENT. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442200 MENTOR SMOOTH ROUND MODERATE PROFILE 300CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 233713 00081317001249

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention