BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTLEY

    MDR report key: 281746 · Received June 9, 2000

    Report

    Report Number
    MW1019106
    Event Type
    Injury
    Date Received
    June 9, 2000
    Date of Event
    February 29, 2000
    Report Date
    June 9, 2000
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE IN THE HOSP FOR ABDOMINAL SURGERY PT WORE ALP/SCD COMPRESSION BOOTS TO PREVENT DVT. WHEN THE BOOTS WERE REMOVED AFTER 2 DAYS PT HAD NUMBNESS IN CALF AND FOOT OF LEFT LEG. PT IS NOW BEING TREATED WITH PHYSICAL THERAPY TO TRY TO REGAIN FEELING IN THE LEG.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/24/00: MEDICAL CTR WAS CONTACTED REGARDING THE COMPLAINT FILED BY THE PT. A REP OF THE HOSP WAS AWARE OF THE COMPLAINTS MADE BY THE PT AND STATED THE HOSP DID NOT FEEL THE INJURY WAS DUE TO THE HUNTLEIGH FLOWTRON DVT PROPHYLAXIS INTERMITTENT COMPRESSION SYSTEM, AND THEREFORE DID NOT SEND THE PRODUCT BACK TO THE MFR AND HAD THE PRODUCT TESTED BY THEIR OWN SERVICES DEPT. NO MALFUNCTIONS WERE FOUND. THE FLOWTRON DVT PROPHYLAXIS SYSTEM WORKS BY INTERMITTENTLY COMPRESSING THE MUSCLES OF THE LEG, WHICH MIMICS THE ACTION OF WALKING, THEREBY HELPING TO PREVENT THROMBUS FORMATION. THE PUMP OPERATES ON A 60 SECOND CYCLE CONSISTING OF 12 SECONDS OF INFLATION FOLLOWED BY 48 SECONDS OF DEFLATION, ONE LEG AT A TIME. IT IS CO'S RECOMMENDATION THAT THE GARMENTS BE APPLIED SNUGLY TO THE PT'S EXTREMITIES TO ENSURE THE LEG IS FULLY COMPRESSED DURING INFLATION. IF THERE IS A PROBLEM WITH THE PUMP OR THE GARMENT, THE PUMPS AUDIBLE AND VISUAL ALARM WILL GO OFF. BASED UPON THE ABOVE, MFR DOES NOT BELIEVE THAT THE FLOWTRON SYSTEM CAUSED ANY INJURY TO THE PT. A FOLLOW-UP LETTER HAS BEEN SENT TO THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUNTLEY ALP/SCD COMPRESSION BOOTS JOW HUNTLEIGH HEALTHCARE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R