BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8571589 · Received May 1, 2019

    Report

    Report Number
    1645337-2019-10918
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 11, 2019
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 05/22/2019, 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. ON 05/28/2019, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON 06/07/2019, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE REPORTED INFORMATION, THE PATIENT EXPERIENCED A DEFLATION IN THE BREAST IMPLANT. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE APPEARED INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO ADDITIONAL ANOMALIES WERE OBSERVED. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. THE REPORTED COMPLAINT WAS NOT CONFIRMED. DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. POSSIBLE CAUSES OF DEFLATION OF SALINE-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA TO THE BREAST. 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 OF RIGHT BREAST PROSTHESIS. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS, CATALOG #3501670, LOT #243384. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESES ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363997 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 243384 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention