BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9845101 · Received March 17, 2020

    Report

    Report Number
    1645337-2020-04411
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    January 1, 2018
    Report Date
    February 26, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 14, 2020, THE PRODUCT INVESTIGATION WAS COMPLETED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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. DEVICE INVESTIGATION SUMMARY: DURING VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE POSTERIOR VIEW OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. A TEAR MEASURING APPROXIMATELY 0.3 CM WAS ALSO OBSERVED WITHIN THE CREASE/FOLD. THE EVALUATION DETERMINED THAT THE DEFLATION IS CONSISTENT WITH A CREASE FOLD DEFLATION. A CREASE/FOLD FAILURE IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES. A SECOND PRODUCT WAS RECEIVED (PRODUCT CODE 3501670 AND LOT NUMBER 5933290) AND IS A CONCOMITANT DEVICE (CONTRALATERAL). NO ADVERSE EVENTS WERE REPORTED FOR THIS DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, SUFFERED LEFT SIDE DEFLATION POST-OPERATIVELY. THE PATIENT STATED THAT THE LEFT SIDE WAS SMALLER, FELT LIKE "PLUG" IN IT, AND CHANGED SHAPE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON MARCH 10, 2020 WITH THE FOLLOWING DEVICES: (LEFT) 650CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505650BC LOT: 7621282 SN: (B)(4) AND (RIGHT) 650CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505650BC LOT: 9351787 SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305587 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501670 5851682 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention