BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 11341082 · Received February 17, 2021

    Report

    Report Number
    1645337-2021-01663
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    October 10, 2020
    Report Date
    January 26, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001355
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 2, 2021, MENTOR RECEIVED A DEVICE WITH A DIFFERENT LOT NUMBER THAN WHAT WAS INITIALLY REPORTED. THE DEVICE WAS A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE (CATALOG: 3502200 LOT: 6812841). ON MARCH 9, 2021, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE RECEIVED DEVICE WAS THE SUSPECT MEDICAL DEVICE. THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. 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. ON MARCH 16, 2021, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MPPS DV 200CC BREAST IMPLANT HAD A TEAR ON THE ANTERIOR VIEW, MEASURING APPROXIMATELY 1.0 CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN AN AREA OF THE TEAR, MEASURING APPROXIMATELY 0.1 CM. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE OF THE RUPTURE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 VALID LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. 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 FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION WITH A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS ON THE RIGHT SIDE, SUFFERED RIGHT BREAST IMPLANT DEFLATION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR SALINE IMPLANT ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237442 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502200 6812841 00081317001355

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention