BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 16112062 · Received January 6, 2023

    Report

    Report Number
    2438477-2022-00130
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    October 20, 2022
    Report Date
    January 6, 2023
    Manufacturer
    KAP MEDICAL
    Product Code
    FNM
    UDI-DI
    00822383257471
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A LATERAL ROTATION MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER OF THE UNIT REPORTED THAT THE "PUMP IS CONSTANTLY RUNNING AND WILL NOT FILL THE AREA WHERE SHE IS LYING". THE END USER REPORTEDLY NOW HAS 5 BED SORES, WHICH ARE BEING TREATED BY HER HOME HEALTH AIDE. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635039 DRIVE MEDICAL MATTRESS FNM KAP MEDICAL LS9500 00822383257471

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other