BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 11658177 · Received April 13, 2021

    Report

    Report Number
    3006942524-2021-00006
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    December 29, 2020
    Report Date
    March 23, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317025450
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IN ADDITION, THE PATIENT¿S INITIALS WERE KMH, THE DATE OF BIRTH WAS (B)(6) 1977, THE REPLACEMENT DEVICE IS MENTOR MEMORYGEL XTRA BREAST IMPLANT 295CC. THE PROCEDURE WAS AN AUGMENTATION REVISION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING THE VISUAL EVALUATION OF THE SILTEX MOD+PROF XTRA 295CC, A TEAR WAS OBSERVED IN THE ANTERIOR VIEW MEASURING APPROXIMATELY 1.8 CM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A SEROMA IS A BUILD-UP OF FLUID AROUND THE IMPLANT. SYMPTOMS FROM A SEROMA MAY INCLUDE SWELLING, PAIN, AND BRUISING. A SEROMA MAY OCCUR SOON AFTER SURGERY, OR ANY TIME LATER ON, WHICH WOULD BE REFERRED TO AS A LATE SEROMA. WHILE THE BODY MAY ABSORB SEROMAS, SOME MAY REQUIRE SURGERY FOR DRAINAGE. AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR BECAME AWARE THAT SECTION D3 MANUFACTURER ZIP CODE WAS REPORTED INCORRECTLY. THE ACTUAL ZIP CODE IS (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).THE ACTUAL ZIP CODE IS (B)(6).

    Additional Manufacturer Narrative · 1

    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. ON 3/29/2021, MENTOR RECEIVED A PHOTO OF THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 7559857 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ON 4/12/2021, UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. A SEROMA IS A BUILD-UP OF FLUID AROUND THE IMPLANT. SYMPTOMS FROM A SEROMA MAY INCLUDE SWELLING, PAIN, AND BRUISING. A SEROMA MAY OCCUR SOON AFTER SURGERY, OR ANY TIME LATER ON, WHICH WOULD BE REFERRED TO AS A LATE SEROMA. WHILE THE BODY MAY ABSORB SEROMAS, SOME MAY REQUIRE SURGERY FOR DRAINAGE. AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: EARLY ONSET SEROMA. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 295CC AND SUFFERED FROM AN EARLY ONSET SEROMA ON THE LEFT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557295 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS TMPX295 7559857 00081317025450

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention