BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEG WRAP BLANKET

    MDR report key: 2112389 · Received May 25, 2011

    Report

    Report Number
    1313850-2011-00116
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DEVICE INVOLVED IN COMPLAINT IS NOT KNOWN, THEREFORE, NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER EIGHT HOURS OF BEING OFF COOLING PROTOCOL BLISTERS WERE NOTED ON THE PT'S LEFT LEG BELOW THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEG WRAP BLANKET LEG WRAP BLANKET ILO STRYKER CORP DBA GAYMAR DHL540 NA

    Patients

    Seq Age Sex Outcome Treatment
    1