BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CONTOUR PROFILE MODERATE GEL ¿ LUMERA

    MDR report key: 7597160 · Received June 13, 2018

    Report

    Report Number
    1645337-2018-03662
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 15, 2018
    Report Date
    May 24, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06/19/2018, 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

    ON 07/23/2018, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR CONTOUR PROFILE MODERATE GEL ¿ LUMERA GEL BREAST PROSTHESIS. THE CATALOG NUMBER IS 324-1057 AND THE LOT NUMBER IS 5622494. ON 07/31/2018, 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 08/06/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, THE GEL CONTAINED IN THE DEVICE APPEARS CLEAR. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. YELLOW MATERIAL WAS OBSERVED ON THE SHELL SURFACE. THE PRODUCT EVALUATION (PE) TEAM DISCOVERED PARALLEL LINES OF SHELL WEAR ON THE ANTERIOR ASPECT, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE DISCOVERED. COMPLAINT WAS NOT CONFIRMED. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET; HOWEVER, COMPLAINT TRENDS FOR MENTOR DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE. MANUFACTURER¿S REFERENCE NUMBER: (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. CONCOMITANT PRODUCTS: UNSPECIFIED MENTOR GEL BREAST PROSTHESIS, CATALOG AND LOT NUMBERS BOTH UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES WHEN THE LEFT PROSTHESIS RUPTURED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018. DURING EXPLANTATION SURGERY, THE DOCTOR OBSERVED THAT THE RIGHT PROSTHESIS HAD RUPTURED AS WELL. THE EXPLANTED DEVICES WERE REPLACED WITH ALLERGAN BRAND BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439793 MENTOR CONTOUR PROFILE MODERATE GEL ¿ LUMERA PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5622494

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention