BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGER

    MDR report key: 1932238 · Received December 8, 2010

    Report

    Report Number
    3004542876-2010-00019
    Event Type
    Other
    Date Received
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ARIZANT HEALTHCARE, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED THAT THEY HAD 4 INSTANCES OF REDNESS, ONE OF WHICH RESULTED IN A BLISTER. THEY CANNOT CONFIRM THAT IT WAS CAUSED BY ARIZANT PRODUCTS. IT WAS ALSO REPORTED THAT ONE EVENT MAY HAVE OCCURRED WHEN ARIZANT PRODUCTS WERE NOT BEING USED. NO ADDITIONAL CONFIRMATION IS FORTHCOMING, SO THIS REPORT IS FILED WITH THE INFORMATION CURRENTLY AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other