BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON EXCEL

    MDR report key: 436572 · Received January 9, 2003

    Report

    Report Number
    2431480-2003-00001
    Event Type
    Injury
    Date Received
    January 9, 2003
    Date of Event
    November 18, 2002
    Report Date
    January 7, 2003
    Manufacturer
    HUNTLEIGH HEALTHCARE
    Product Code
    JOW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED UNILATERAL LEG & KNEE PAIN WITH DIFFICULTY MOVING ANKLE AFTER TUMMY TUCK AND THIGH LIPOSUCTION SURGERY. INTERMITTENT PNEUMATIC COMPRESSION DEVICE WITH CALF-LENGTH GARMENTS IN USE INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON EXCEL INTERMITTENT PNEUMATIC COMPRESSION DEVICE FOR DVT PREVENTION JOW HUNTLEIGH HEALTHCARE AC 550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 2002 BILATERAL PADDING UNDER KNEES| INTRA-OPERATIVELY.