BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10115198 · Received June 3, 2020

    Report

    Report Number
    1645337-2020-06845
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000525
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED A RUPTURE IN THE BREAST IMPLANT. DURING THE VISUAL EVALUATION, THE DEVICE WAS OBSERVED TO BE RUPTURED. THE DEVICE WAS RECEIVED INCOMPLETE. MICROSCOPIC EXAMINATION OF THE EDGES OF THE TEAR REVEALED PARALLEL STRIATIONS THAT ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS 5983305 LOT NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. RUPTURE COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. REASON FOR DEVICE EXPLANT AND/ OR REOPERATION: IMPLANT EXCHANGE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DISCOVERED DURING AN IMPLANT EXCHANGE SURGERY PERFORMED ON (B)(6) 2020. THE PATIENT HAD BOTH OF HER EXPLANTED BREAST PROSTHESES REPLACED WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 550CC SALINE BREAST PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577529 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504504BC 5983305 00081317000525

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention