BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 15998697 · Received December 16, 2022

    Report

    Report Number
    1645337-2022-15156
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    July 19, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005247
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PROSTHESIS RUPTURE. 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).

    Additional Manufacturer Narrative · 0

    ON 30-DEC-2022, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE EVENT DATE IS 19-JUL-2022. THE PATIENT RACE IS WHITE AND ETHNICITY IS NOT HISPANIC/LATINO. THE IMPLANTATION DATE IS (B)(6) 2015. THE PATIENT AGE AT THE TIME OF EVENT IS 59 YEARS OLD. THE PATIENT¿S LEFT BREAST PROSTHESIS IS A MENTOR MEMORYSHAPE BREAST IMPLANT 620CC GEL BREAST PROSTHESIS, CATALOG #3341402, LOT #6904120, UDI #(B)(4), PMA #P060028. 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. MRI RESULTS INDICATED RIGHT BREAST PROSTHESIS RUPTURE ONLY. THIS REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. BLOCK B1 IS PRODUCT PROBLEM NO LONGER APPLIES TO THIS REPORT NOR DOES H6 MEDICAL DEVICE PROBLEM CODE MATERIAL RUPTURE (A0412). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 630CC GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868338 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3341402 6904120 00081317005247

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention