BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7896486 · Received September 20, 2018

    Report

    Report Number
    1645337-2018-05722
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    May 20, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000105
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 10/24/2018, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICE WAS RECEIVED BY THE FAILURE ANALYSIS LAB ON 09/13/2018. ON 10/30/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, TWO DEVICES WITHOUT LOT NUMBER ENGRAVED WERE RETURNED. THE GEL CONTAINED ON BOTH DEVICES APPEARS CLEAR. RED AND WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICES. RED AND YELLOW MATERIAL WITH GEL WAS OBSERVED ON THE SHELL SURFACES. MENTOR PRODUCT ANALYSIS LAB DISCOVERED ON DEVICE A AN AREA OF MISSING MATERIAL MEASURING APPROXIMATELY 3.0 CM X 1.5 CM ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. DEVICE B HAD TWO RENTS MEASURING APPROXIMATELY 11.5 CM AND 1.0 CM WITHIN A CREASE ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE RED, YELLOW AND WHITE MATERIAL FOUND ON THE DEVICE. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET; HOWEVER, COMPLAINT TRENDS FOR MENTOR DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE. 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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE WAS DIAGNOSED BY MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736034 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 230515 00081317000105

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention