BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8449953 · Received March 25, 2019

    Report

    Report Number
    1645337-2019-09663
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    February 26, 2018
    Report Date
    February 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001263
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 4/17/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. YELLOW AND BROWN MATERIALS WERE OBSERVED WITHIN THE DEVICE AND WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING INITIAL EVALUATION A CREASE WAS OBSERVED ON THE ANTERIOR ASPECT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND IT REVEALED A RENT WITHIN CREASE ON THE ANTERIOR ASPECT, MEASURING APPROXIMATELY 0.3 CM. NO OTHER ANOMALIES WERE OBSERVED. DEFLATION COMPLAINT WAS CONFIRMED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. THE COMPLAINT WAS CONFIRMED SINCE A RENT WITHIN A CREASE WAS FOUND ON THE DEVICE. THESE FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDER-INFLATION OR OVER-INFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS CAPSULAR CONTRACTURE OR TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 201786, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE YELLOW, BROWN AND WHITE MATERIALS. SINCE THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THERE ARE NEITHER DEFICIENCIES ALLEGED NOR PATIENT INJURIES. THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE 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. 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. CONCOMITANT MEDICAL PRODUCTS: 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501655 LOT: 201786. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, EXPERIENCED RIGHT SIDE DEFLATION POST-OPERATIVELY. DEFLATION WAS CONFIRMED VIA MAMMOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240741 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 201786 00081317001263

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention