BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 19696787 · Received July 8, 2024

    Report

    Report Number
    1645337-2024-08080
    Event Type
    Injury
    Date Received
    July 8, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317006916
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 20-AUG-2024, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: IT WAS PREVIOUSLY REPORTED THAT IT WAS THE PATIENT DEVELOPED PAIN IN HER LEFT BREAST AND THAT HER LEFT BREAST PROSTHESIS FLIPPED OVER. ADDITIONAL INFORMATION RECEIVED STATES THAT IT WAS THE PATIENT¿S RIGHT BREAST THAT DEVELOPED PAIN AND HER RIGHT BREAST PROSTHESIS THAT FLIPPED. THE RIGHT BREAST PROSTHESIS FLIPPED ABOUT 4 WEEKS POST IMPLANTATION. A SURGICAL INTERVENTION WAS PERFORMED TO REPOSITION THE PROSTHESIS. THE BREAST PROSTHESIS FLIPPED AGAIN ABOUT 6 WEEKS AFTER THE SURGICAL INTERVENTION. THE BREAST PROSTHESIS WAS LATER EXPLANTED ON (B)(6) 2023 AS A RESULT. THE SUSPECT MEDICAL DEVICE IS A MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS, CATALOG #3505320BC, LOT #9619339, SERIAL #(B)(6), UDI #(B)(4), PMA #P030053. 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. 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 REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PAIN, BREAST PROSTHESIS FLIPPED OVER. 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 PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SMOOTH GEL BREAST PROSTHESIS DEVELOPED PAIN AND DISCOMFORT IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE BREAST PROSTHESIS FLIPPED OVER. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESES ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142684 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9619339 00081317006916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention