BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGER

    MDR report key: 1933455 · Received December 14, 2010

    Report

    Report Number
    3004542876-2010-00020
    Event Type
    Other
    Date Received
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: ACTUAL DEVICE USED NOT AVAILABLE. RESULTS: RECORDS OF THE SAME LOT WERE EVALUATED AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    PT DEVELOPED RAISED RED MARKS WHERE THE BLANKET TAPE ATTACHED TO THE PT SKIN. REPORTEDLY OCCURRED TO A LESSER EXTENT ON THREE OTHER PTS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER PATIENT WARMING THERAPY DWJ ARIZANT HEALTHCARE INC. 570 SA9975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other