BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8956219 · Received September 3, 2019

    Report

    Report Number
    1645337-2019-18278
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    May 1, 2012
    Report Date
    August 5, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 21, 2020. AN EXPLANT HAS BEEN SCHEDULED FOR (B)(6) 2020. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE 2. IS OTHER SERIOUS- UNCHECK 2. IS REQUIRED INTERVENTION- CHECK MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 1/21/2020. THE IMPACTED PRODUCT WAS A 550CC MENTOR MEMORYGEL BREAST IMPLANT. THE LOT AND SERIAL NUMBERS WERE ALSO OBTAINED. ALL NEW INFORMATION MADE AVAILABLE HAS BEEN POPULATED IN SECTION D AND H4. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 5993166 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. 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) ASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH UNKNOWN MENTOR GEL IMPLANTS EXPERIENCED BILATERAL BAKER¿S GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE PATIENT DESCRIBED FIRMNESS, TIGHTNESS, PAIN NEAR THE SIDES OF HER ARMPITS, NECK DISCOMFORT, AND DISCOMFORT REACHING UP AND BEHIND. THE SYMPTOMS WERE STATED TO BE MORE PRONOUNCED ON THE LEFT SIDE. THE PATIENT HAD CONSULTED WITH A SURGEON AND FUTURE EXPLANT IS INDICATED, HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. SEE 1645337-2019-18281 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751821 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5993166

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R