BEUDAMED
    FDA Adverse Event Other Summary report: N

    EBICE

    MDR report key: 261412 · Received February 4, 2000

    Report

    Report Number
    2242816-2000-00003
    Event Type
    Other
    Date Received
    February 4, 2000
    Date of Event
    October 1, 1999
    Report Date
    October 26, 1999
    Manufacturer
    EBI, L.P.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO DR, IT WAS NOTED AT A POST-OPERATIVE FOLLOW-UP VISIT THAT THE PT HAD "ABRASIONS" ON THE LEG. THESE WERE NOT IN THE AREA BEING TREATED BY THE EBICE DEVICE. DR FEELS THEY MAY BE FROM WHERE THE SURGICAL TAPE WAS ON THE PT'S SKIN. THIS MDR IS BEING SUBMITTED FOR INFORMATIONAL PURPOSES ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBICE CONTROLLED COLD THERAPY ILO EBI, L.P. 2750H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other