BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 11944646 · Received June 6, 2021

    Report

    Report Number
    1645337-2021-06341
    Event Type
    Injury
    Date Received
    June 6, 2021
    Date of Event
    April 1, 2020
    Report Date
    May 17, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001386
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER CLINICAL/SECONDARY REVIEW OF THIS FILE PERFORMED ON 06/24/2021, IT WAS DECIDED TO ADD CODES BREAST MASS AND SURGICAL INTERVENTION TO MORE ACCURATELY CAPTURE THE REPORTED EVENT FOR THE LEFT SIDE. IN ADDITION, ON 6/17/2021, MENTOR BECAME AWARE THAT THE PATIENT EXPERIENCED COMPLETE ASYMMETRY OF THE LEFT BREAST AND THE RIGHT BREAST. ON 6/29/2021 , THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. ON 7/6/2021, MENTOR CONDUCTED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SM MPPS DV 275CC BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND REVEALED A LEAKAGE, CAUSED BY VALVE DELAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A SECOND PRODUCT WAS RECEIVED (LOT-5914051). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4) AFTER CLINICAL/SECONDARY REVIEW OF THIS FILE PERFORMED ON 06/24/2021, IT WAS DECIDED TO ADD CODES BREAST MASS AND SURGICAL INTERVENTION TO MORE ACCURATELY CAPTURE THE REPORTED EVENT FOR THE LEFT SIDE.

    Additional Manufacturer Narrative · 0

    ON 7/14/2021, A STATEMENT ¿ASYMMETRY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: CONTRACTURE OF THE FIBROUS CAPSULE, SEROMA OR HEMATOMA, DEVELOPMENT OF POSTOPERATIVE BREAST DYSPLASIA, UNILATERAL DISCREPANCY IN MUSCLE DEVELOPMENT, DEFLATION OF THE IMPLANT, INCORRECT CHOICE OF IMPLANT SHAPE OR SIZE, AND SURGICAL TECHNIQUE. ASYMMETRY IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET.¿ WAS ADDED TO THE PRODUCT INVESTIGATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 7/12/2021, MENTOR BECAME AWARE THAT THE DATE OF IMPLANTATION WAS ACTUALLY (B)(6) 2009. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). ON 7/12/2021, MENTOR BECAME AWARE THAT THE DATE OF IMPLANTATION WAS ACTUALLY (B)(6) 2009.

    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. NOTE: EXPLANT DATE IS (B)(6) 2021. 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: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC AND SUFFERED FROM A DEFLATION ON THE LEFT SIDE. THE PATIENT ALSO HAD UNDERGONE BIOPSY ON THE LEFT SIDE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANT ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840949 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502275 5914051 00081317001386

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention