BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRONA PORTABLE DVT DEVICE 6300

    MDR report key: 6311637 · Received February 6, 2017

    Report

    Report Number
    MW5067744
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 6, 2017
    Manufacturer
    DEVON MEDICAL PRODUCTS
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CIRONA PORTABLE DVT DEVICE 6300. AT DISCHARGE IT WAS FOUND THAT THE DEVICE HAD OVERHEATED AND MELTED THE OUTER CASING. NO INJURY TO PT. DEVICE REMOVED FROM PT AND NEW DEVICE GIVEN TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89111 CIRONA PORTABLE DVT DEVICE 6300 SLEEVE, LIMB, COMPRESSIBLE JOW DEVON MEDICAL PRODUCTS 6300

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention CIRONA PORTABLE DVT DEVICE FOR 4 HOURS