BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYFIX

    MDR report key: 709456 · Received May 5, 2006

    Report

    Report Number
    9710332-2006-00001
    Event Type
    Injury
    Date Received
    May 5, 2006
    Date of Event
    March 4, 2006
    Report Date
    April 28, 2006
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Product Code
    LHN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT. RECEIVED 2ND OF 3 RADIOTHERAPY FRACTIONS USING THE TOTAL BODY CUSHION FOR POSITIONING. AFTER TREATMENT PT. WANTED TO GET UP FROM THE TABLE AND HAD NEW RIGHT FOOT DROP (LATER INFORMATION FROM HOSPITAL STATED LEFT FOOT DROP). PT. ENCOUNTERED A BRUISING AND SWELLING OF LOWER LEG AREA. PT. WAS FITTED WITH A LEG BRACE (LATER INFORMATION FROM HOSPITAL STATED BRUISING AND SWELLING OCCURRED TWO DAYS LATER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYFIX BODYFIX 14 BLUEBAG TOTAL BODY LHN MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R