BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9587878 · Received January 14, 2020

    Report

    Report Number
    1645337-2020-00807
    Event Type
    Injury
    Date Received
    January 14, 2020
    Report Date
    December 26, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 01/14/2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: A SERIAL NUMBER WAS PROVIDED FOR THE DEVICE. THIS REPORT IS FOR THE PATIENT¿S RIGHT DEVICE. IT IS A MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL BREAST PROSTHESIS, CATALOG #3506001BC, LOT # 5944124, SERIAL # (B)(6), UDI # (B)(4), PMA # P030053. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IT WAS INITIALLY REPORTED THAT THE IMPLANTATION DATE IS (B)(6) 2010. NEW INFORMATION STATES THAT THE IMPLANTATION DATE IS (B)(6) 2010. THE PATIENT DOB IS (B)(6) 1980. THE EXPLANTATION DATE IS (B)(6) 2019. ON 01/24/2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE PATIENT DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS. PATIENT WAS ALSO DIAGNOSED WITH BILATERAL ACQUIRED ABSENCE OF BREAST AND NIPPLE. THE PATIENT WAS DIAGNOSED WITH A BRCA2 GENE MUTATION. THE REMOVED BREAST PROSTHESES WERE DISCARDED AFTER EXPLANTATION SURGERY. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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 MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BILATERAL IMPLANT RUPTURE, GENERALIZED ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED AFTER IMPLANTATION. IN ADDITION, THE PATIENT REPORTED THAT SHE SUFFERED FROM MULTIPLE HEALTH ISSUES CONNECTED TO HER IMPLANTS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT DEVICES IN 2019. THIS MEDWATCH REPORT IS FOR THE 2ND OF TWO BREAST PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51210 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5944124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention