BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 16380555 · Received February 15, 2023

    Report

    Report Number
    1645337-2023-01737
    Event Type
    Injury
    Date Received
    February 15, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005216
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 10-MAR-2023, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE SUSPECT MEDICAL DEVICE IS A MENTOR MEMORYSHAPE BREAST IMPLANT 440CC GEL BREAST PROSTHESIS, CATALOG #3341252, LOT #7295465, SERIAL #(B)(6), UDI #(B)(4), PMA #P060028. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. - AN IMPLANTATION DATE OF (B)(6) 2017 WAS REPORTED. - IT WAS REPORTED THAT THE RIGHT BREAST CAPSULAR CONTRACTURE IS BAKER GRADE IV. NO BAKER GRADE WAS REPORTED FOR THE LEFT BREAST. THIS REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. - THE PATIENT AGE AT THE TIME OF EVENT IS 57 YEARS OLD. - THE PATIENT RACE IS WHITE AND ETHNICITY IS NOT HISPANIC/LATINO. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 22-MAR-2023, 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).

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH UNSPECIFIED MENTOR BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT HAS BEEN DEFAULTED TO GEL BREAST IMPLANT DUE TO UNKNOWN TYPE, AND THE COMMON DEVICE NAME AND PROCODE ARE BEING REPORTED FOR SUBMISSION PURPOSES ONLY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S 2ND OF TWO BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943773 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3341252 7295465 00081317005216

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other