BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGER

    MDR report key: 1942984 · Received December 20, 2010

    Report

    Report Number
    3004542876-2010-00021
    Event Type
    Other
    Date Received
    December 20, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - ANALYZED INFO PROVIDED TO MFR. RESULTS AND CONCLUSION - WHILE NOT CONFIRMED, IT SEEMS VERY UNLIKELY THAT THIS DEVICE CAUSED THE EVENT. THE WARMING WAS APPLIED WITH A CLOTH BLANKET BETWEEN THE WARMER AND THE PT IN A PHYSICAL LOCATION WHERE THE PT WAS NOT BEING WARMED.

    Description of Event or Problem · 1

    PT DEVELOPED RAISED REDNESS AND BLISTERS ON SACRAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER PATIENT WARMING THERAPY DWJ ARIZANT HEALTHCARE INC. 505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other