BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMSCO

    MDR report key: 163215 · Received April 16, 1998

    Report

    Report Number
    163215
    Event Type
    Injury
    Date Received
    April 16, 1998
    Date of Event
    December 24, 1997
    Report Date
    March 6, 1998
    Manufacturer
    AMSCO CORP QA
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 5 LITER PLASTIC BAG OF SALINE IRRIGANT WARMED IN WARMING CABINET USED AS POSITIONING DEVICE DURING SURGERY. PT REC'D 3RD DEGREE BURN REQUIRING SKIN GRAFTING. TEMP MEASUREMENTS INSIDE THE CABINETS RANGED FROM 38.1 C TO 83.1 C WITH AVG READINGS RANGING FROM 39.8 TO 63.8 C. WARMING CABINETS WERE SET AT 170 F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO WARMING CABINETS LGZ AMSCO CORP QA M70 WC-EL *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R