BEUDAMED
    FDA Adverse Event Summary report: N

    LYMPHATROL

    MDR report key: 12166 · Received March 21, 1994

    Report

    Report Number
    MW4000333
    Date Received
    March 21, 1994
    Report Date
    February 8, 1994
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Product Code
    JOW
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE 86-YR-OLD WOMAN, SEVERELY OSTEOPOROTIC, HAD FRACTURED HER PELVIS NINE MONTHS EARLIER AND WAS CONFINED TO A WHEELCHAIR DURING THE DAY. BOTH LEGS HAD BECOME VERY EDEMATOUS FROM DEPENDENCY AND LACK OF MOVEMENT. THE PNEUMATIC BOOTS WERE APPLIED FOR ONE HR, INTERMITTENTLY COMPRESSING THE THREE SEGMENTAL SEGMENTS TO THE LOWEST PRESSURE, ABOUT 45 MM HG. THAT NIGHT SHE COMPLAINED OF SEVERE PAIN IN THE LEGS AND REFUSED TO USE IT AGAIN. SINCE THE PAIN WAS NOT IMMEDIATE, DR CONVINCED HER TO TRY IT AGAIN TWO DAYS LATER, WITH THE SAME RESULT OF SEVERE PAIN HRS LATER. IT WAS NOT USED AGAIN BUT SEVERAL DAYS LATER THE CALF WAS VERY RED, SWOLLEN AND FLUCTUANT. SUSPECTING AN ABSCESS, DR ASPIRATED, CONTAINING CLEAR YELLOW FLUID THAT GREW NO ORGANISMS; EVIDENTLY A SEROMA. SINCE THEN DR HAS CONTROLLED HER EDEMA WITH ELASTIC BANDAGES WHENEVER SHE IS OUT OF BED, AND NO LASTING HARM HAS RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYMPHATROL JOW HUNTLEIGH HEALTHCARE, INC. AC 340

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR