BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 13909690 · Received March 25, 2022

    Report

    Report Number
    1645337-2022-03352
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    February 15, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000303
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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. 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: N/A. . MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    AFTER CLINICAL/SECONDARY REVIEW OF THIS FILE PERFORMED ON JUNE 15, 2022, IT WAS DECIDED TO REMOVE HEALTH EFFECT - CLINICAL CODE "DEFORMITY/DISFIGUREMENT" (E2308) AND TO UPDATE IT TO "LOCAL REACTION" (E040203), TO MORE ACCURATELY CAPTURE THE REPORTED EVENT. MAMMOGRAM FOUND AN IRREGULAR ANECHOIC MATERIAL LATERAL AND DEEP TO THE RIGHT IMPLANT WITH THE APPEARANCE OF FLUID. SECTION H. 6. HEALTH EFFECT - CLINICAL CODE: LOCAL REACTION (E040203).

    Additional Manufacturer Narrative · 0

    ON MAY 28, 2022, MENTOR BECAME AWARE THAT THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (RIGHT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504254BC LOT: 9703966 SN: (B)(6) AND (LEFT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504254BC LOT: 9577423 SN: (B)(6). IN ADDITION, THE SUSPECT MEDICAL DEVICES HAS BEEN DISCARDED. THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. ON JUNE 8, 2022, AN ANALYSIS OF THE SUSPECT MEDICAL DEVICE'S PHOTO WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, THE IMPLANT WAS OBSERVED RUPTURED. AS THE PRODUCT INVOLVED IN THIS COMPLAINT WAS DISCARDED, THE DEVICE COULDN´T BE ANALYZED ACCORDING TO OUR PROCEDURES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    ON MARCH 29, 2022, MENTOR BECAME AWARE THAT THE PATIENT HAS BEEN SCHEDULED FOR IMPLANT REMOVAL SURGERY ON (B)(6) 2022. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE.

    Additional Manufacturer Narrative · 0

    UPDATED DEVICES' PHOTO EVALUATION COMPLETED ON JULY 19 , 2022: UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, THE IMPLANT WAS OBSERVED RUPTURED. AS THE PRODUCT INVOLVED IN THIS COMPLAINT WAS DISCARDED, THE DEVICE COULDN´T BE ANALYZED ACCORDING TO OUR PROCEDURES. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH SPONTANEOUS RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052752 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503501BC 6897737 00081317000303

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention| O