BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7363691 · Received March 22, 2018

    Report

    Report Number
    1645337-2018-01703
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    January 18, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001867
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC SALINE PROSTHESIS. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL PROSTHESES ON (B)(6) 2018. THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING EXAMINATION, THE PRODUCT EVALUATION TEAM OBSERVED A RENT MEASURING APPROXIMATELY 0.6 CM ON THE POSTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE FOUND. THE COMPLAINT WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 5976691 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. 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 3/15/2018. 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. CONCOMITANT PRODUCTS: LEFT MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC SALINE PROSTHESIS, LOT NUMBER: 5994439, CATALOG NUMBER: 3542412. MANUFACTURER¿S REFERENCE NUMBER: (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 4/12/2018, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC SALINE PROSTHESIS. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205914 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5976691 00081317001867

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention