BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9892280 · Received March 27, 2020

    Report

    Report Number
    1645337-2020-04948
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    December 1, 2019
    Report Date
    March 5, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 26-APR-2020, A MANUFACTURING RECORD EVALUATION (MRE) WAS COMPLETED, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE SUSPECT MEDICAL 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MENTOR FAILURE ANALYSIS LAB HAS COMPLETED THE EVALUATION OF THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: DURING A VISUAL EVALUATION AN AREA OF MISSING MATERIAL WAS OBSERVED ON THE ANTERIOR VIEW, MEASURING APPROXIMATELY 1.4 CM X 1.1 CM. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. CAUSES OF DEFLATION OF SALINE IMPLANTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA, EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA SUCH AS THAT WHICH CAN OCCUR DURING VIGOROUS EXERCISE, ATHLETICS, ETC. A SECOND PRODUCT WAS RECEIVED (5915457). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL 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 MENTOR 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION OF IMPLANT, 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
    353620 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501660 5915457 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention