BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN

    MDR report key: 7530357 · Received May 21, 2018

    Report

    Report Number
    3012316249-2018-00028
    Event Type
    Injury
    Date Received
    May 21, 2018
    Report Date
    May 21, 2018
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER RETURNED A DIFFERENT SERIAL NUMBER AND DIFFERENT ITEM OF REPORTED DEVICE. SERIAL NUMBER (B)(4) AND ITEM 4800 WAS RETURNED FOR INSPECTION. INSPECTOR DID NOT REALIZE IT WAS A DIFFERENT ITEM/DIFFERENT SERIAL NUMBER AT TIME OF REPORT. CUSTOMER INITIALLY REPORTED SERIAL NUMBER (B)(4) AND ITEM MER-4500 IN EMAIL, SENT IN A PICTURE OF SERIAL NUMBER (B)(4), AND RETURNED SERIAL NUMBER (B)(4) AND ITEM 4800.

    Description of Event or Problem · 1

    THE END-USER FELL OUT OF BED SUSTAINING A HEAD INJURY AND HAD TO BE TRANSPORTED BY AMBULANCE. THE END-USER RECEIVED STITCHES. BED RAILS WERE NOT IN USE WHEN THE PATIENT FELL. NO VISIBLE DEFECT WITH THE AIR MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372670 MERIDIAN 8" APM SYSTEM FNM EEZCARE MEDICAL CORP. 4800

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O