BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 16547330 · Received March 15, 2023

    Report

    Report Number
    1645337-2023-03009
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 17, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317003861
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 16-MAR-2023, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH THE SUSPECT MEDICAL DEVICE. - RIGHT BREAST PROSTHESIS RUPTURE WAS DIAGNOSED VIA MRI. SIDE OF RUPTURE WAS UNKNOWN WHEN INITIAL REPORT WAS SUBMITTED. AS A RESULT, THE FOLLOWING UPDATES WERE MADE NOW THAT IT IS KNOWN THAT THE RUPTURED DEVICE IS FROM PATIENT¿S RIGHT BREAST: BRAND NAME: MENTOR MEMORYGEL BREAST IMPLANT CATALOG NUMBER: 3504504BC. LOT NUMBER: 6775352 SERIAL NUMBER: (B)(6) UDI #: (B)(4) PMA #: P030053 - THE PATIENT AGE AT THE TIME OF EVENT IS 32 YEARS OLD. - AN UPDATED EVENT DATE (17-FEB-2023) WAS REPORTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 29-JUN-2023, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. ON 06-JUL-2023, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: IT WAS REPORTED THAT THE CORRECT LOT NUMBER FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS IS 6685771 AND THE CORRECT SERIAL NUMBER IS (B)(6). IT IS A MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESIS, CATALOG #3504754BC, AND THE UDI NUMBER IS (B)(4). 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: BREAST PROSTHESIS RUPTURE, CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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 ON LOT #6685771 AND LOT #6775352, 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 MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. INFORMATION FOR THE PATIENT¿S TWO BREAST PROSTHESES WAS REPORTED: LEFT DEVICE: CATALOG #3504754BC, LOT #6685771, SERIAL #(B)(4) RIGHT DEVICE: CATALOG #3504504BC, LOT #6775352, SERIAL #(B)(4) THE SIDE OF THE RUPTURED BREAST PROSTHESIS (LEFT OR RIGHT) WAS NOT SPECIFIED. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768953 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504504BC 6685771 00081317003861

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention| O