BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10715770 · Received October 21, 2020

    Report

    Report Number
    1645337-2020-13456
    Event Type
    Injury
    Date Received
    October 21, 2020
    Report Date
    October 2, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 31-DEC-2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE SUSPECT MEDICAL DEVICE IS THE PATIENT¿S RIGHT BREAST PROSTHESIS. IT IS A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS, CATALOG #3544507, LOT #169633, UDI #(B)(4), PMA #P030053. 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. THE PATIENT DOB IS (B)(6)1967. THE PATIENT RACE IS WHITE. THE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH THE SUSPECT MEDICAL DEVICE. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS DEVELOPED PAIN IN ONE OF HER BREASTS. AS A RESULT, THE PATIENT HAD AN MRI PERFORMED THAT SHOWED THAT THE BREAST PROSTHESIS HAD RUPTURED, AND THE SILICONE IS LEAKING INTO THE CAPSULE. 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
    1179579 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 169633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other