BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9896411 · Received March 30, 2020

    Report

    Report Number
    1645337-2020-04210
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    March 11, 2020
    Report Date
    March 11, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 20, 2020, MENTOR COMPLETED EVALUATION OF THE DEVICE. DEVICE EVALUATION SUMMARY: DURING VISUAL EVALUATION OF THE SAMPLE A TEAR WAS OBSERVED ON THE POSTERIOR ASPECT, MEASURING 0.6 CM. PLEASE NOTE THAT DUE TO INSUFFICIENT PAPERWORK, THE ANALYSIS FROM THE PRODUCT EVALUATION LAB WAS LIMITED TO NON-DESTRUCTIVE TESTING. OUR OBSERVATIONS MAY DIFFER FROM YOUR ORIGINAL FINDINGS. IF YOU WOULD LIKE US TO CONDUCT A MORE EXHAUSTIVE ANALYSIS, PLEASE COMPLETE THE ATTACHED FORM AND SEND IT BACK BY REPLYING TO THIS MESSAGE. ONCE THE FORM IS RECEIVED, THE DEVICE WILL BE THOROUGHLY ANALYZED VIA MICROSCOPIC EXAMINATION AND A NEW LETTER WILL BE PROVIDED. IF THE FORM WAS RECENTLY PROVIDED, PLEASE DISREGARD THIS ADDITIONAL REQUEST. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT NUMBER 6900380 WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. RUPTURE COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. ON 4/27/2020, IT WAS NOTICED THE FOLLOWING WAS ERRONEOUSLY OMITTED FROM THE PREVIOUSLY SUBMITTED REPORT: THE PATIENT'S RIGHT SIDE DEVICE WAS A MENTOR MEMORYGEL BREAST IMPLANT, 400CC, CATALOG# 3504001BC MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON APRIL 8, 2020, 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. UPON RECEIPT OF THE DEVICE, THE LOT NUMBER WAS IDENTIFIED AS 6900380. THE DEVICE WAS 400CC. 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: NOT APPLICABLE. RUPTURES WERE DISCOVERED DURING A REVISION PROCEDURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS. DURING A REVISION PROCEDURE ON (B)(6) 2020, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND BOTH REMOVED DEVICES WERE DISCOVERED TO BE RUPTURED. THE PATIENT WAS REPLACED WITH 415CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER SHPX415, LEFT-SIDED SERIAL NUMBER (B)(4), RIGHT-SIDED SERIAL NUMBER (B)(4)). THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360500 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6900380

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention