BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS

    MDR report key: 8177215 · Received December 18, 2018

    Report

    Report Number
    1645337-2018-07438
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12/19/2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: IT WAS INITIALLY REPORTED THAT THE DATE OF EVENT IS (B)(6) 2018, THE SAME DATE AS THE EXPLANTATION OF THE SUSPECT MEDICAL DEVICES. NEW INFORMATION STATES THAT THE PATIENT HAD A BILATERAL MAMMOGRAM THAT SHOWED RIGHT IMPLANT RUPTURE AND THAT PATIENT WAS 74 AT THE TIME OF THE EVENT. DATE OF EVENT HAS BEEN CHANGED TO ESTIMATE OF (B)(6) 2018. THE PATIENT¿S DATE OF BIRTH IS 11/19/1943. SHE WAS 74 YEARS OLD AT THE TIME OF THE EVENT. THE PROCEDURE FOR THE SUSPECT MEDICAL DEVICES WAS A BREAST AUGMENTATION REVISION. IT WAS REPORTED THAT IMPLANTATION HAPPENED IN THE 1980S. DATE OF IMPLANTATION HAS BEEN ESTIMATED TO BE (B)(6)1980. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD UNKNOWN MENTOR GEL PROSTHESES IMPLANTED EXPERIENCED BILATERAL RUPTURE OF THE BREAST PROSTHESES. THE DETAILS OF THE RUPTURE ARE UNKNOWN AT THE TIME OF THIS REPORT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL PROSTHESES ON (B)(6) 2018; CATALOG # 3502754BC, S/NS: (B)(4) (L) AND (B)(4) (R). THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2018-07439 FOR THE CONTRALATERAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014488 UNKNOWN GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention