BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8638603 · Received May 23, 2019

    Report

    Report Number
    1645337-2019-12587
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 1, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001317
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6)2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED A DEFLATION OF THE BREAST IMPLANT WAS REPORTED. DURING EVALUATION OF THE SAMPLE SOME CREASES WERE OBSERVED ON THE ANTERIOR AND POSTERIOR VIEW. LEAK TESTING REVEALED A TEAR MEASURING APPROXIMATELY 0.1 CM WITHIN THE CREASE NOTED ON THE ANTERIOR ASPECT. 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: UNDERINFLATED 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 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 AND FUNCTIONALLY TESTED 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6790607, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. 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: MATERIAL RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE PROSTHESIS AND EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 600CC SALINE PROSTHESES WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428767 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6790607 00081317001317

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention