BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 14978480 · Received July 11, 2022

    Report

    Report Number
    2438477-2022-00046
    Event Type
    Injury
    Date Received
    July 11, 2022
    Date of Event
    May 28, 2021
    Report Date
    July 11, 2022
    Manufacturer
    EEZCARE MEDICAL CORP
    Product Code
    FNM
    UDI-DI
    00822383221618
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS CONTACTED REGARDING A REPORTED INJURY INVOLVING A ALTERNATING PRESSURE MATTRESS LOW AIR LOSS SYSTEM, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER REPORTED HAVING DEVELOPED A PRESSURE WOUND ON HER BOTTOM PRIOR TO COMMENCING USE OF THE DEVICE. AFTER APPROXIMATELY EIGHT MONTHS OF USING THE DEVICE, HER CARETAKERS BEGAN TO NOTICE THE DEVELOPMENT OF ADDITIONAL PRESSURE WOUNDS, AND SHE WAS TAKEN TO THE HOSPITAL. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE PROVIDED A REPLACEMENT MODEL TO THE END USER, AND IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058572 DRIVE LOW AIR LOSS MATTRESS FNM EEZCARE MEDICAL CORP 14027 00822383221618

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization