BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9126340 · Received September 26, 2019

    Report

    Report Number
    1645337-2019-20279
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    December 11, 2018
    Report Date
    May 10, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000488
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 10/8/2019, IT WAS DISCOVERED THAT THE AWARENESS DATE WAS REPORTED INCORRECTLY IN 3500A INITIAL REPORT. THE ACTUAL AWARENESS DATE WAS 4/09/2019. THE DUE DATE FOR THE REPORT WAS 5/09/2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 05/10/2019, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. CONCOMITANT PRODUCT: MENTOR MEMORYGEL BREAST IMPLANT 350CC, CATALOG NUMBER: 3503504BC, SN: (B)(4), LOT 6962671. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. ON 05/17/2019 , DURING EVALUATION OF THE SAMPLE A CREASE WAS OBSERVED IN THE ANTERIOR VIEW. NO ADDITIONAL ANOMALIES WERE OBSERVED. BASED ON THE FACTS OF THE CASE, IS UNRELATED TO THE BREAST IMPLANT AND RELATED TO THE PATIENT CONDITION. THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. 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. THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S PSR EXEMPTION # E2007003. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD ASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV AFTER IMPLANTATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916039 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7346384 00081317000488

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention