BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DVT CALF GARMENTS STANDARD

    MDR report key: 3080681 · Received April 4, 2013

    Report

    Report Number
    1419652-2013-00085
    Event Type
    Injury
    Date Received
    April 4, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP.Z.O.O.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT OUR DVT10 IS CAUSING SKIN ISSUES (SWELLING AND REDNESS). WE DETERMINED THAT THE ISSUES WERE BEING CAUSED BY THE APPLICATION OF THE WRONG SIZE GARMENT. PT WERE NEEDING A DVT20 BECAUSE THE DVT10 IS TOO SMALL, CAUSING THE INCREASED PRESSURE ON THE SKIN. PLEASE REF MFR # 3007420694-2013-00018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137608 DVT CALF GARMENTS STANDARD DVT JOW ARJOHUNTLEIGH POLSKA SP.Z.O.O. DVT10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization