BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGAR WARMING SYSTEM

    MDR report key: 227080 · Received June 10, 1999

    Report

    Report Number
    MW1016494
    Event Type
    Other
    Date Received
    June 10, 1999
    Date of Event
    May 5, 1997
    Report Date
    May 13, 1997
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 5/5/99 THE PT UNDERWENT AN ABDOMINAL MYOMECTOMY, "CHROMPERTUBATION AND DRAINAGE OF A LEFT OVARIAN CYST. DURING THE SURGERY AN UPPER EXTREMITY BAIR HUGGAR BLANKET AND BAIR HUGGAR WARMING SYSTEM WERE USED. THE PT WAS SUBSEQUENTLY FOUND TO HAVE A BURN ON THE INNER ASPECT OF HER LEFT UPPER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGAR WARMING SYSTEM WARMING UNIT DWJ AUGUSTINE MEDICAL, INC. 500/OR *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other BAIR HUGGAR WARMING BLANKET.