BEUDAMED
    FDA Adverse Event Death Summary report: N

    DOLPHIN FIS MATTRESS

    MDR report key: 7603229 · Received June 14, 2018

    Report

    Report Number
    3009402404-2018-00032
    Event Type
    Death
    Date Received
    June 14, 2018
    Date of Event
    February 13, 2018
    Report Date
    July 5, 2018
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CONFIRMED TO BE A DOLPHIN FIS MATTRESS AND CONTROL UNIT. VISUAL INSPECTION OF THE PRODUCT FOR PRODUCT IDENTIFICATION WAS PERFORMED. THE PRODUCT REMAINS IN THE FAMILIES POSSESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "SISTER ALLEGES HER BROTHER PURCHASED A DOLPHIN MATTRESS THAT WAS DEFECTIVE, (HAD A HOLE IN IT) MADE HIM SICK, CAUSED HIM TO BE HOSPITALIZED AND RESULTED IN HIS DEATH." AT CURRENT, THE PRODUCT HAS NOT BEEN CONFIRMED BY THE MANUFACTURER AS A DOLPHIN AS THE PRODUCT IS STILL IN THE FAMILIES POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445841 DOLPHIN FIS MATTRESS PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DLPH-35820000J-M

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death