BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9680130 · Received February 7, 2020

    Report

    Report Number
    1645337-2020-02001
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    August 1, 2019
    Report Date
    January 15, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000273
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON MARCH 12, 2020, 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. ON MARCH 12, 2020, MENTOR BECAME AWARE THAT THE PATIENT EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE ON THE RIGHT SIDE CORRECTION: AFTER CLINICAL REVIEW OF THIS FILE PERFORMED ON MARCH 12, 2020, IT WAS DECIDED TO ADD CODE OFF-LABEL USE TO MORE ACCURATELY CAPTURE THE REPORTED EVENT MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. CONCOMITANT MEDICAL PRODUCTS: 275CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3502751BC, SERIAL # (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144239 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3502751BC 7719930 00081317000273

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other