BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTICOM PROGRESSIVE DVT DEVICE

    MDR report key: 381001 · Received March 4, 2002

    Report

    Report Number
    MW1024285
    Event Type
    Injury
    Date Received
    March 4, 2002
    Date of Event
    February 17, 2002
    Report Date
    March 4, 2002
    Manufacturer
    DYNAMIC AIR INC.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOOT FULLY INFLATED ON LEFT FOOT WHICH WAS OPERATIVE LEG. IT POPPED OFF THE FOOT PORTION BUT WAS STILL STRAPPED AROUND PT'S ANKLE, REMAINED FULLY INFLATED AND RESTRICTED CIRCULATION. LEFT CREASE MARK ON ANKLE THAT EVENTUALLY RESOLVED. PT WAS COMPLAINING OF "TERRIBLE PAIN" AS THIS OCCURRED.

    Description of Event or Problem · 1

    BOOT FULLY INFLATED ON LEFT FOOT WHICH WAS OPERATIVE LEG. IT POPPED OFF THE FOOT PORTION BUT WAS STILL STRAPPED AROUND PT'S ANKLE, REMAINED FULLY INFLATED AND RESTRICTED CIRCULATION. LEFT CREASE MARK ON ANKLE THAT EVENTUALLY RESOLVED. PT WAS COMPLAINING OF "TERRIBLE PAIN" AS THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTICOM PROGRESSIVE DVT DEVICE DVT BOOTS JOW DYNAMIC AIR INC. * 6D483

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention