BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7602353 · Received June 14, 2018

    Report

    Report Number
    1645337-2018-03679
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 21, 2018
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/11/2018, 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. A CREASE WAS OBSERVED ON THE POSTERIOR ASPECT, IN ADDITION A RENT WAS DISCOVERED WITHIN THE CREASE, MEASURING APPROXIMATELY 0.3 CM. COMPLAINT WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, THE PRODUCT EVALUATION (PE) TEAM CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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).

    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 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST IMPLANTS WHICH PATIENT NOTICED LEFT SIDE DEFLATION AFTER IMPLANTATION. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH CATALOG NUMBER 3501660, LOT NUMBER 6872221, AND SERIAL NUMBER (B)(4) ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444296 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 7490475 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention