BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1484183 · Received September 20, 2009

    Report

    Report Number
    1484183
    Event Type
    Malfunction
    Date Received
    September 20, 2009
    Date of Event
    August 17, 2009
    Report Date
    September 20, 2009
    Manufacturer
    SOUTHWEST TECHNOLOGIES, INC
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MICROWAVE HOT PACK WAS APPLIED TO PT'S RIGHT ELBOW. REDNESS WAS NOTED, BUT NO BURN. THREE DAYS LATER, PT RETURNED TO CLINIC FOR NEXT VISIT, WITH HEALING AREA WHERE HOT PACK HAD BEEN PLACED. THE AREA LOOKED LIKE A BLISTER FROM A BURN WHICH HAD POPPED AND WAS NOW HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * GEL HOT PACK, MICROWAVE IMD SOUTHWEST TECHNOLOGIES, INC CC102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR