BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUIDOTHERAPY FT110 SINGLE

    MDR report key: 2103793 · Received May 24, 2011

    Report

    Report Number
    9616086-2011-00066
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    LSB
    PMA / PMN Number
    K011243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT GOT CELLEX MEDIUM IN HER FACE AFTER TREATMENT WAS COMPLETED. PATIENT HAD A REACTION TO THE CELLEX AND WAS TREATED IN THE HOSPITAL FOR RESPIRATORY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUIDOTHERAPY FT110 SINGLE FLUIDOTHERAPY LSB DJ ORTHOPEDICS DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other