BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7301388 · Received February 27, 2018

    Report

    Report Number
    1645337-2018-01016
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 26, 2018
    Report Date
    January 29, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE FAILURE ANALYSIS, IT WAS DISCOVERED THAT THE DEVICE RETURNED TO MENTOR WAS NOT THE ORIGINALLY REPORTED COMPLAINT DEVICE. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE IN AN EFFORT TO GET ADDITIONAL INFORMATION REGARDING THIS DISCREPANCY, BUT NONE WAS MADE AVAILABLE. SINCE THE REPORTED PRODUCT (LOT #5586305, CATALOG #3544425) WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF WRONG PRODUCT CLARIFICATION IS RECEIVED AT A LATER DATE, WITHIN THE LAB PRODUCT RETENTION PERIOD, WE WILL PERFORM THE INVESTIGATION AS APPROPRIATE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/14/2018, ADDITIONAL INFORMATION INDICATED THAT THE INITIAL IMPLANTATION DATE IS (B)(6) 2006. THE CATALOG NUMBER FOR THE LEFT IMPLANT IS 3544425, LOT NUMBER IS 5586305, AND THE SERIAL NUMBER IS (B)(4). CONCOMITANT PRODUCTS: RIGHT CATALOG NUMBER 3544425, SERIAL NUMBER (B)(4), LOT NUMBER 1010522. ON 6/6/2018, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 03/13/2018, THE MENTOR FAILURE ANALYSIS LAB HAS 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. ON 04/06/2018, MENTOR RECEIVED INFORMATION THAT THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENTS WITH FOLLOWING DEVICES: LEFT MENTOR MEMORYGEL 500CC, SERIAL NUMBER (B)(4), CATALOG NUMBER 3505004BC. RIGHT MENTOR MEMORYGEL 500CC, SERIAL NUMBER (B)(4), CATALOG NUMBER 3505004BC. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR GEL DEVICE ON (B)(6) 2006 EXPERIENCE LEFT BREAST TENDERNESS AND BURNING SENSATION. THE PATIENT SAW HER SURGEON AND PER MD'S OBSERVATION, THE PATIENT'S LEFT DEVICE IS RUPTURED. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143868 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5586305

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention