BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 15340913 · Received September 1, 2022

    Report

    Report Number
    1645337-2022-10304
    Event Type
    Injury
    Date Received
    September 1, 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
    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 FOR BOTH LOT NUMBER 7311598 AND LOT NUMBER 6905459, 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: THE PATIENT HAS NOT UNDERGONE EXPLANTATION OR REOPERATION AT THIS TIME. 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 JANUARY 06, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION. MENTOR BECAME AWARE THAT THE PATIENT EXPERIENCED PAIN IN HER RIGHT BREAST INCISION SITE AND GENERAL PAIN IN BOTH BREASTS. THE PATIENT ALSO DEVELOPED FATIGUE, BRAIN FOG, AND STERNAL PAIN WHEN TAKING DEEP BREATHS. THE PATIENT EXPERIENCED GENERALIZED ILLNESS. AS SUCH, ANISOMASTIA IS NO LONGER APPLICABLE. A SECOND FILE WAS GENERATED FOR THE LEFT PROSTHESIS TO DOCUMENT THE PATIENT'S INCIDENCE OF GENERALIZED ILLNESS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-00401 FOR THE CONTRALATERAL EVENT. H6 HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON DECEMBER 12, MENTOR RECEIVED ADDITIONAL INFORMATION. THE PATIENT'S DATE OF BIRTH WAS ADDED AS (B)(6) 1951. THE PATIENT'S ETHNICITY WAS ADDED AS NON HISPANIC. THE PATIENT'S RACE WAS ADDED AS WHITE. THE IMPACTED DEVICE WAS IDENTIFIED AS: SERIAL NUMBER: (B)(6). LOT NUMBER: 6905459. THE PRODUCT'S SIDE OF IMPLANTATION WAS IDENTIFIED AS THE RIGHT BREAST. THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE PATIENT'S RIGHT BREAST PROSTHESIS WAS RUPTURED. AS SUCH, BREAST MASS IS NO LONGER APPLICABLE. THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. 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 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT NOTICED A LUMP ON AN UNDISCLOSED SIDE. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE LOT AND SERIAL NUMBERS WERE PROVIDED FOR BOTH IMPLANTED DEVICES, BUT THE IMPACTED SIDE WAS NOT DISCLOSED TO MENTOR. THE LEFT SIDE WAS IDENTIFIED AS SERIAL NUMBER (B)(4) AND THE RIGHT SIDE WAS IDENTIFIED AS SERIAL NUMBER (B)(4) BOTH DEVICES HAVE THE SAME CATALOG NUMBER. AS SUCH, THE LOT AND SERIAL NUMBER FOR EACH DEVICE HAVE BOTH BEEN POPULATED IN THE LOT AND SERIAL NUMBER FIELDS. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137882 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503501BC 6905459 00081317000303

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| O