BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7720100 · Received July 25, 2018

    Report

    Report Number
    1645337-2018-04523
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    April 6, 2018
    Report Date
    June 28, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000693
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL, CATALOG: 3543507, LOT: 223173. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES. BILATERAL RUPTURE AND CAPSULAR CONTRACTURE WERE IDENTIFIED BY ULTRASOUND AND MAMMOGRAM. RIGHT BREAST HEMATOMA WAS ALSO REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560119 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 00081317000693

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention