BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 6707408 · Received July 12, 2017

    Report

    Report Number
    2438477-2017-00011
    Event Type
    Injury
    Date Received
    July 12, 2017
    Report Date
    January 9, 2017
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    UDI-DI
    00822383221618
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE IMPORTER/ INITIAL DISTRIBUTOR OF THE DEVICE. CAREGIVER ACQUIRED THE DEVICE (B)(6) 2016 FROM A DME PROVIDER. PATIENT USED THE UNIT FOR A MONTH BEFORE SEVERAL BED SORES WERE DISCOVERED. INITIAL TREATMENT WAS IN-HOUSE BY NURSE VISITATION. PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. PATIENT BEEN IN AND OUT OF THE HOSPITAL TO TREAT BLISTERS. CAREGIVER ADVISED THAT THE UNIT WAS INSTALLED BY DME PROVIDER. THERE IS NO REPORT OF ANY PRODUCT DEFECT AND/OR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488530 DRIVE MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM EEZCARE MEDICAL CORP. 14027 00822383221618

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization