BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 9246256 · Received October 28, 2019

    Report

    Report Number
    1645337-2019-22656
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    September 2, 2019
    Report Date
    October 2, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001416
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: DURING VISUAL INSPECTION OF THE DEVICE IT WAS OBSERVED WITH NO APPARENT DAMAGE. LEAK TESTING REVEALED THERE WAS LEAKAGE FROM THE VALVE. NO ADDITIONAL ANOMALIES WERE OBSERVED. 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. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING 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 · 0

    ON 11/29/2019, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DATE OF EVENT WAS ON (B)(6) 2019. PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: LEFT REPLACED WITH SERIAL NUMBER (B)(4), CATALOG NUMBER 3504254BC AND RIGHT REPLACED WITH SERIAL NUMBER (B)(4) AND CATALOG NUMBER 3504254BC. 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 (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. CONCOMITANT MEDICAL PRODUCTS: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC SALINE BREAST IMPLANT,CAT#:3502350, LOT#; 5904026. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAS IT REMOVED AND REPLACED WITH ANOTHER MENTOR GEL DEVICE ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041679 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5904026 00081317001416

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention