BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 14977335 · Received July 11, 2022

    Report

    Report Number
    2438477-2022-00051
    Event Type
    Injury
    Date Received
    July 11, 2022
    Report Date
    July 11, 2022
    Manufacturer
    EEZCARE MEDICAL CORP
    Product Code
    FNM
    UDI-DI
    00822383110820
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS CONTACTED REGARDING A REPORTED INJURY INVOLVING A BARIATRIC LOW AIR LOSS MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER REPORTED DEVELOPING A PRESSURE SORE WHILE USING THE DEVICE. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE HAS ATTEMPTED TO CONTACT THE END USER TO GATHER ADDITIONAL INFORMATION AND RETRIEVE THE PRODUCT FOR EVALUATION, BUT THERE HAS BEEN NO RESPONSE. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057439 DRIVE LOW AIR LOSS MATTRESS FNM EEZCARE MEDICAL CORP 14029 00822383110820

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other