BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON DVT 30

    MDR report key: 458345 · Received May 8, 2003

    Report

    Report Number
    2431480-2003-00002
    Event Type
    Injury
    Date Received
    May 8, 2003
    Report Date
    May 8, 2003
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Product Code
    JOW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL ELDERLY PTS ON POSTOPERATIVE ORTHOPEDIC SURGERY FLOOR DEVELOPED "PRESSURE ULCERS" WHILE USING THE FLOWTRON THIGH-LENGTH GARMENTS IN CONJUNCTION WITH JOBST FAST-FIT GRADUATED COMPRESSION STOCKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON DVT 30 THIGH LENGTH PNEUMATIC COMPRESSION GARMENT FOR OUT PREVENTIN JOW HUNTLEIGH HEALTHCARE, INC. DVT 30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN JOBST FAST-FIT GRADUATED COMPRESSION STOCKING.