BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 16907064 · Received May 10, 2023

    Report

    Report Number
    1645337-2023-05595
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 1, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000280
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAY 16, 2023, AN ANALYSIS OF THE SUSPECT MEDICAL DEVICE'S PHOTO WAS COMPLETED. INVESTIGATION SUMMARY: UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. INFECTION, MANIFESTED BY SWELLING, TENDERNESS, PAIN AND FEVER, MAY APPEAR IN THE IMMEDIATE POSTOPERATIVE PERIOD OR AT ANY TIME AFTER INSERTION OF THE IMPLANT. IN THE ABSENCE OF CLASSIC SYMPTOMS, SUBACUTE OR CHRONIC INFECTIONS MAY BE DIFFICULT TO DIAGNOSE. IF INFECTION DOES NOT SUBSIDE PROMPTLY WITH THE APPROPRIATE TREATMENT, REMOVAL OF THE IMPLANT IS INDICATED. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY. PER A DATABASE QUERY, THIS IS THE ONLY REPORTED COMPLAINT OF INFECTION AGAINST THIS LOT NUMBER. THE MENTOR MICROBIOLOGY DEPARTMENT HAS PROVIDED INFORMATION ON THE STERILITY LOT FOR THE IMPLANTED DEVICE INDICATING THAT IT MET ALL STERILIZATION PARAMETERS REQUIRED TO PROVIDE A 10E-6 STERILITY ASSURANCE LEVEL PRIOR TO RELEASE FOR DISTRIBUTION. PRODUCT EVALUATION CONCLUDED THE REPORTED INFECTION OCCURRED FROM A SOURCE OTHER THAN THE DEVICE. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, CAPA ACTIVITY WAS NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    ON JULY 16, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE SUSPECT MEDICAL DEVICE WAS IMPLANTED FOR BREAST AUGMENTATION REVISION. IT WAS REPLACED WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3503001BC LOT: 9860592 SN: (B)(6)).

    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. 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: INFECTION. 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).

    Additional Manufacturer Narrative · 0

    ON JUNE 28, 2023, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE PATIENT IDENTIFIER WAS UPDATED TO (B)(6). THE PATIENT'S DATE OF BIRTH WAS REPORTED TO BE (B)(6) 1997. ON JULY 06, 2023, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SM MPP GEL 300CC RETURNED DEVICE. INFECTION, MANIFESTED BY SWELLING, TENDERNESS, PAIN, AND FEVER, MAY APPEAR IN THE IMMEDIATE POSTOPERATIVE PERIOD OR AT ANY TIME AFTER INSERTION OF THE IMPLANT. IN THE ABSENCE OF CLASSIC SYMPTOMS, SUBACUTE OR CHRONIC INFECTIONS MAY BE DIFFICULT TO DIAGNOSE. IF THE INFECTION DOES NOT SUBSIDE PROMPTLY WITH THE APPROPRIATE TREATMENT, REMOVAL OF THE IMPLANT IS INDICATED. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY. PER A DATABASE QUERY, THIS IS THE ONLY REPORTED COMPLAINT OF INFECTION AGAINST THIS LOT NUMBER. THE MENTOR MICROBIOLOGY DEPARTMENT HAS PROVIDED INFORMATION ON THE STERILITY LOT FOR THE IMPLANTED DEVICE INDICATING THAT IT MET ALL STERILIZATION PARAMETERS REQUIRED TO PROVIDE A 10E-6 STERILITY ASSURANCE LEVEL BEFORE RELEASE FOR DISTRIBUTION. PRODUCT EVALUATION CONCLUDED THE REPORTED INFECTION OCCURRED FROM A SOURCE OTHER THAN THE DEVICE. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, CAPA ACTIVITY WAS NOT REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICE WAS AN UNSPECIFIED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881780 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503001BC 9754398 00081317000280

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention