BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI COLD THERAPY PRODUCTS

    MDR report key: 173618 · Received June 15, 1998

    Report

    Report Number
    MW4002275
    Event Type
    Malfunction
    Date Received
    June 15, 1998
    Date of Event
    June 5, 1998
    Report Date
    June 12, 1998
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD EBI COLD PACK ON RT KNEE. PACK BUBBLED OUT OVER LATERAL SIDE OF RT KNEE. REDDENED AREA 8CM BY 10CM. PT HAS DECREASED MOVEMENT IN RT FOOT. PT DID HAVE AN ANTERIOR CRUCIATE LIGAMENT REPAIR ON 6-4-98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI COLD THERAPY PRODUCTS COLD PACK IMD EBI MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other