BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 11704484 · Received April 21, 2021

    Report

    Report Number
    1645337-2021-04358
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    January 15, 2020
    Report Date
    April 1, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000501
    PMA / PMN Number
    P030053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 30-MAR-2022, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: CLARIFICATION WAS RECEIVED ON WHICH BREAST DEVELOPED CAPSULAR CONTRACTURE. IT WAS THE PATIENT¿S RIGHT BREAST THAT DEVELOPED CAPSULAR CONTRACTURE. THE PRODUCT INFORMATION HAS BEEN UPDATED TO REFLECT WHAT WAS REPORTED FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. IT IS A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS, CATALOG #3504004BC, LOT #5665767, SERIAL # (B)(6), UDI #(B)(4), PMA #P030053. AN UPDATED EVENT DATE OF 15-JAN-2020 WAS REPORTED. 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 (MRE) FOR LOT #5640372 AND LOT #5665767 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: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR SMOOTH GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN ONE OF HER BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. INFORMATION WAS PROVIDED FOR THE PATIENT¿S BREAST PROSTHESES (LEFT DEVICE: MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS, CATALOG #3503754BC, LOT #5640372, SERIAL # (B)(4). RIGHT DEVICE: MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS, LOT #5665767, SERIAL # (B)(4)). IT WAS NOT SPECIFIED WHICH BREAST DEVELOPED CAPSULAR CONTRACTURE. IF CLARIFICATION ON WHICH BREAST DEVELOPED CAPSULAR CONTRACTURE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596355 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504004BC 5665767 00081317000501

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other