BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS

    MDR report key: 7449213 · Received April 20, 2018

    Report

    Report Number
    1645337-2018-02359
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    February 1, 2017
    Report Date
    March 26, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06/12/2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE EVENT DATE WAS ORIGINALLY REPORTED AS (B)(6) 2017. NEW INFORMATION STATES THAT THE EVENT DATE IS (B)(6) 2017. THE EXPLANTATION DATE WAS ORIGINALLY REPORTED AS (B)(6) 2018. NEW INFORMATION STATES THAT THE EXPLANTATION DATE IS (B)(6) 2018. THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND HIGH PROFILE 330CC SALINE BREAST PROSTHESIS, CATALOG #3503330, LOT NUMBER #5993136, PMA #P990075, UDI # (B)(4). A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT¿S EXPLANTED DEVICES WERE REPLACED WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 400CC SALINE BREAST PROSTHESES. ON 06/15/2018, THE MENTOR FAILURE ANALYSIS LAB 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 9/20/2018 INDICATED THAT THE REPLACEMENT DEVICES ARE AS FOLLOW: RIGHT REPLACED WITH CATALOG NUMBER 3502400, SERIAL NUMBER (B)(4), AND LEFT REPLACED WITH CATALOG NUMBER 3502400, SERIAL NUMBER (B)(4). (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 LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 07/03/2018, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. ON 07/10/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. THE PRODUCT EVALUATION (PE) TEAM OBSERVED MULTIPLE CREASES ON THE ANTERIOR AND POSTERIOR ASPECT. LEAK TESTING, ACCORDING WITH MENTOR PROCEDURES, REVEALED A RENT IN LENGTH IN THE VICINITY OF THE VULCANIZATION DOT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT REVEALED NO INDICATION AS TO ITS CAUSE. NO OTHER ANOMALIES WERE DISCOVERED. COMPLAINT WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PE CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. INVESTIGATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS IDENTIFIED THE MOST PROBABLE CAUSE AS STRESS CONCENTRATION AT THE ANTERIOR VULCANIZED REGION OF THE SHELL. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. 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; HOWEVER, DEFLATION TRENDS FOR MENTOR SALINE-FILLED DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH UNKNOWN MENTOR SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS DIAGNOSED BY DOCTOR¿S EXAMINATION. AS A RESULT, PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291447 MENTOR SMOOTH ROUND MODERATE PLUS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5993136

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention