BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAR HUGGER

    MDR report key: 25492 · Received August 8, 1995

    Report

    Report Number
    25492
    Event Type
    Injury
    Date Received
    August 8, 1995
    Date of Event
    January 24, 1995
    Report Date
    March 21, 1995
    Manufacturer
    PROGRESSIVE DYNAMICS, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERSONNEL DISCONNECTED BLANKET FROM UNIT PLACING TUBING APPROX 6 INCHES FROM PT'S HAND. DEVICE USED AT A MID-TEMPERATURE RANGE FOR LOCAL WARMING OF HAND FOR APPROX 30-45 MINUTES. 2 1/2 HOURS AFTER SURGERY PT AWOKE WITH SEVERE LEFT HAND PAIN. REDNESS AND EDEMA OF HAND NOTED, 2ND DEGREE BURN OF HAND DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR HUGGER HYPERTHERMIA UNIT DWJ PROGRESSIVE DYNAMICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention