BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9837100 · Received March 16, 2020

    Report

    Report Number
    1645337-2020-04260
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    November 1, 2019
    Report Date
    February 24, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 30, 2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. IN ADDITION, THE PATIENTS PREVIOUSLY UNKNOWN DEVICE WAS CONFIRMED TO BE A MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE BREAST IMPLANT, CATALOG# 3501650, LOT# 5980833. ON APRIL 13, 2020, MENTOR COMPLETED EVALUATION OF THE DEVICE. DEVICE EVALUATION SUMMARY: DURING VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE ANTERIOR VIEW OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. A TEAR MEASURING APPROXIMATELY 0.1 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. 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. DEFLATION COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. 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) ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH UNKNOWN MENTOR IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300476 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5980833

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention