BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANACEA

    MDR report key: 1046393 · Received May 17, 2008

    Report

    Report Number
    2438477-2008-00005
    Event Type
    Injury
    Date Received
    May 17, 2008
    Report Date
    May 16, 2008
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE HAD BEEN USED IN A NURSING HOME. IT WAS ALLEGED THAT THERE WAS A "BUBBLING" OR AN AIR BLADDERS IN THE MIDDLE SECTION OF THE MATTRESS WHICH CAUSED TWO NURSING HOME RESIDENTS TO SLIDE OFF THE SIDES OF THE MATTRESS AND ALLEGEDLY INJURED THEMSELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANACEA LOW AIR LOSS MATTRESS SYSTEM FNM EEZCARE MEDICAL CORP. 14028DS-3580 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention