BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9504691 · Received December 20, 2019

    Report

    Report Number
    1645337-2019-26005
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    November 23, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317003861
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6926357, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JUNE 15TH, 2020 ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE EXPLANTED ON ON (B)(6) 2020. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    SUSPECT DEVICE RECEIVED ON (B)(6) 2020. DEVICE EVALUATION COMPLETED ON (B)(6) 2020: DURING THE VISUAL EVALUATION, THE DEVICE WAS OBSERVED TO BE RUPTURED. MICROSCOPIC EXAMINATION OF THE EDGES OF THE TEAR REVEALED PARALLEL STRIATIONS THAT ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION/RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JUNE, 25TH 2020, ADDITIONAL INFORMATION INDICATES THAT THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENTS WITH MENTOR SMOOTH,ROUND HIGH PROFILE SILICONE GEL IMPLANTS, THE LEFT SIDE IS 500CC, AND THE RIGHT SIDE IS 475CC. 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NA. CONCOMITANT MEDICAL PRODUCTS: MENTOR MEMORYGEL, 500CC SILICONE BREAST IMPLANT, CAT#:3505004BC SN#: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 475CC ON THE RIGHT AND 500CC ON THE LEFT SIDE SILICONE BREAST IMPLANTS WHICH THE RIGHT SIDE RUPTURED AFTER IMPLANTATION. RUPTURE CONFIRMED VIA MAMMOGRAM EXAMINATION. 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
    1299178 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504754BC 6926357 00081317003861

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R