BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9273819 · Received November 4, 2019

    Report

    Report Number
    1645337-2019-21285
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 29, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000334
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 5/9/2019. DEVICE EVALUATION SUMMARY: DURING EVALUATION OF THE SAMPLE IT WAS OBSERVED TO BE INTACT. NO ADDITIONAL ANOMALIES WERE OBSERVED. BASED ON THE FACTS OF THE CASE, THE REPORTED ISSUE IS UNRELATED TO THE BREAST IMPLANT AND RELATED TO THE PATIENT CONDITION. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT DUE TO EXTERNAL CAUSE. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5900448, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S PSR EXEMPTION #E2007003. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MIGRATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH 450CC MENTOR MEMORYGEL BREAST IMPLANTS. NOW THIS PATIENT PRESENTED WITH BREASTS HANGING OFF THE IMPLANTS. IT WAS ALSO REPORTED THAT THE IMPLANTS RUPTURED. AS A RESULT, THE DEVICES WERE EXPLANTED AND REPLACED ON (B)(6) 2019. DURING EXPLANTATION SURGERY, IT WAS OBSERVED THAT THERE WAS NO IMPLANT RUPTURE. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). SEE 1645337-2019-21284 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067346 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5900448 00081317000334

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention