BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8897674 · Received August 15, 2019

    Report

    Report Number
    1645337-2019-17069
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000037
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 9/6/2019. DEVICE EVALUATION SUMMARY: ACCORDING WITH THE INFORMATION IT WAS REPORTED THAT DURING THE PROCEDURE THE PROSTHESIS WAS BROKEN. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5863950, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. DURING EVALUATION OF THE SAMPLE IT APPEARED INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO ANOMALIES WERE OBSERVED. THE SECOND PRODUCT RECEIVED IS A CONCOMITANT DEVICE, NO FURTHER ANALYSIS IS REQUIRED.IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. CONCOMITANT PRODUCTS: 150CC SMOOTH ROUND MODERATE PROFILE MENTOR MEMORYGEL BREAST IMPLANTS CATALOG: 3507150BC LOT: 5863950 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 150CC MENTOR SMOOTH ROUND MODERATE PROFILE MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. A MAGNETIC RESONANCE IMAGERY WAS PERFORMED IN (B)(6) 2019 WHICH CONFIRMED LEFT SIDE BREAST RUPTURE. AS A RESULT, THE PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693337 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5863950 00081317000037

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention