BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 18095854 · Received November 8, 2023

    Report

    Report Number
    1645337-2023-13262
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    March 1, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317007005
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 09, 2023, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT'S EVENT. IT WAS DETERMINED THAT THE IMPACTED DEVICE WAS A 650CC MENTOR MEMORYGEL BREAST IMPLANT WITH CATALOG NUMBER 3505650BC. THE DEVICE LOT NUMBER WAS UPDATED TO 9760785. THE SERIAL NUMBER HAS BEEN UPDATED TO (B)(6). 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. THE DEVICE DATE OF IMPLANTATION WAS UPDATED TO (B)(6) 2023. THE DEVICE DATE OF EXPLANTATION WAS UPDATED TO (B)(6) 2023. THE DATE OF EVENT HAS BEEN REMOVED AS THE EXACT DATE OF THE EVENT IS UNKNOWN. ALL RELEVANT INFORMATION REGARDING THE ADDITIONAL EVENT PROVIDED HAS BEEN DOCUMENTED ON THIS REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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: BREAST PAIN. 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 A BREAST SURGERY WITH AN UNKNOWN MENTOR BREAST PROSTHESIS AND EXPERIENCED BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE. IT IS UNKNOWN IF THE PATIENT¿S DEVICES WERE GEL OR SALINE DEVICES. IN THE ABSENCE OF CLARIFYING INFORMATION, THE DEVICES WILL BE REPORTED WITH SECTIONS D2A AND D2B INDICATING GEL DEVICES. IF ADDITIONAL INFORMATION IS RECEIVED CONFIRMING GEL OR SALINE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743558 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9760785 00081317007005

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention