BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENODYNE

    MDR report key: 255208 · Received December 20, 1999

    Report

    Report Number
    MW1017756
    Event Type
    Injury
    Date Received
    December 20, 1999
    Date of Event
    December 15, 1999
    Report Date
    December 20, 1999
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD VENTRAL HERNIA REPAIR IN 1999. VENODYNE BOOTS WERE APPLIED AFTER SURGERY. ON 12/15/99 RPTR DEVELOPED A RED, RAISED RASH ON BOTH LEGS WITH ITCHING AND BURNING. IT HAD THE APPEARANCE OF A CHEMICAL BURN. SHE ALSO HAD BEEN ON MORPHINE AND WAS EXPERIENCING NAUSEA AND WAS SWEATING. WHEN THE BOOTS AND STOCKINETTES WERE REMOVED FROM HER LEGS THE STOCKINETTE WAS SOAKING WET. RPTR IS NOT SURE IF SHE WAS REACTING TO THE BOOTS, THE SWEATING AND WETNESS OF HER LEGS, OR THE MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENODYNE VINYL BOOT/COMPRESSOR JOW MICROTEK MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R 1. STOCKINETTE UNDER VENODYNES 12/14/99.