BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 16234360 · Received January 24, 2023

    Report

    Report Number
    1645337-2023-00729
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    February 17, 2017
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000273
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 1, 2024, MENTOR BECAME AWARE THAT THE REPLACEMENT DEVICE USED ON THE RIGHT SIDE WAS CATALOG NUMBER 3502751BC; SERIAL NUMBER (B)(6). ON (B)(6) 2018. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). DEVICE EVALUATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED GEL WITH CLEAR APPEARANCE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB¿S VISUAL EXAMINATION INDICATED THE DEVICE APPEARS INTACT AND NO ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RIGHT CAPSULAR CONTRACTURE; BAKER GRADE IV 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

    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).

    Description of Event or Problem · 0

    THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL; SUBJECT ID:940-014. IT WAS REPORTED THAT A 25-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION-AUGMENTATION SURGERY WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE, AND UNKNOWN SIZE UNKNOWN GEL IMPLANT ON THE LEFT AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV POSTOPERATIVELY. AS A RESULT, THE RIGHT SIDE DEVICE WAS EXPLANTED ON (B)(6) 2018. ON (B)(6) 2023, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III, AND THE DEVICE WAS EXPLANTED ON (B)(6) 2019. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689429 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3502751BC 7360235 00081317000273

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention