BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_TISSUE EXPANDERS

    MDR report key: 7494324 · Received May 8, 2018

    Report

    Report Number
    1645337-2018-02594
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    April 30, 2016
    Report Date
    April 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE FEMALE PATIENT IN GROUP 1 WHO HAD MODIFIED RADICAL MASTECTOMY (MRM) UNDERWENT IMMEDIATE BREAST RECONSTRUCTION USING MEDIUM HEIGHT ANATOMIC EXPANDERS (MENTOR SILTEX MEDIUM HEIGHT CONTOUR PROFILE)) AND SUFFERED SEROMA. TITLE: ¿FROM THE ¿¿FAT CAPSULE¿¿ TO THE ¿¿FAT BELT¿¿: LIMITING PROTECTIVE LIPOFILLING ON IRRADIATED EXPANDERS FOR BREAST RECONSTRUCTION TO SELECTIVE KEY AREAS¿ A STUDY WAS PERFORMED TO EVALUATE THE THICKNESS OF THE BREAST IRRADIATED TISSUE TO CREATE A STANDARD PATTERN OF ¿¿PROTECTIVE¿¿ LIPOFILLING INFILTRATION ON LIMITED KEY AREAS THAT COULD RE-ESTABLISH A THICKNESS SIMILAR TO NON-RADIO TREATED TISSUES. THIRTY (30) PATIENTS WERE INCLUDE IN THIS STUDY: 15 PATIENTS WHO HAD MODIFIED RADICAL MASTECTOMY (MRM) WITH IMMEDIATE BREAST RECONSTRUCTION WITH TISSUE EXPANDERS AND PMRT (GROUP 1). AS A CONTROL GROUP, WERE STUDIED 15 PATIENTS WHO HAD MRM AND IMMEDIATE BREAST RECONSTRUCTION WITH TISSUE EXPANDERS THAT WOULD NOT UNDERGO PMRT (GROUP 2) MENTOR DEVICES WERE USED IN THIS STUDY, HOWEVER CATALOG AND LOT NUMBER WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338899 UNK_TISSUE EXPANDERS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other