BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7616804 · Received June 19, 2018

    Report

    Report Number
    1645337-2018-03762
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    March 7, 2018
    Report Date
    May 30, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001218
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE BREAST PROSTHESIS WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2018. THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, THE PRODUCT EVALUATION TEAM OBSERVED A RENT AT THE SHELL TO PATCH JUNCTION. IN ADDITION, A CREASE WAS OBSERVED GOING ACROSS THE ANTERIOR VIEW. MICROSCOPIC EXAMINATION OF THE RENT EDGES GAVE NO INDICATION AS TO ITS CAUSE. NO OTHER ANOMALIES WERE FOUND. BECAUSE MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE RENT EDGES WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 5811615 WAS REVIEWED ON 6/25/2018, AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. 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 RECEIVED THE DEVICE FOR EVALUATION ON 5/31/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE BREAST PROSTHESIS WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456372 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5811615 00081317001218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention