BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE HIGH

    MDR report key: 11984724 · Received June 11, 2021

    Report

    Report Number
    1645337-2021-06667
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 18, 2021
    Product Code
    FWM
    UDI-DI
    00081317001904
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 17, 2021. THE EXPLANT DATE WAS CLARIFIED TO BE (B)(6) 2021. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 28, 2021 MENTOR BECAME AWARE THAT A DEVICE RETURNED UNDER A DIFFERENT EVENT (1645337-2021-063620) BELONGED TO THIS EVENT. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2021. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, LEAK TESTING, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE BREAST IMPLANT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES, AND A TEAR WAS NOTED ON THE ANTERIOR VIEW MEASURING APPROXIMATELY 0.3 CM. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: 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. 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 · 0

    ON (B)(6) 2021 MENTOR RECEIVED CLARIFICATION ON THE DATE OF EXPLANT. THE DEVICE WAS EXPLANTED ON (B)(6) 2021. 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 (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 THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 275CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DISCOVERED DURING REPLACEMENT SURGERY. BILATERAL PROSTHESIS REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC SALINE PROSTHESES WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878709 MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM 3542711 5903187 00081317001904

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention