BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEAM PAC STANDARD BOXED

    MDR report key: 1161193 · Received September 15, 2008

    Report

    Report Number
    1022819-2008-00256
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 20, 2007
    Report Date
    August 20, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINIC COULD NOT DETERMINE THE MODEL NUMBER OF THE DEVICE. THE CLINIC DISPOSED OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURE FOR EVALUATION. THE MANUFACTURE COULD NOT DETERMINE THE ROOT CAUSE AND/OR CONDITIONS THAT LEAD TO THE DEVICE'S REPORTED FAILURE.

    Description of Event or Problem · 1

    A FEMALE PATIENT RECEIVED A BURN DURING THE USE OF A HOT PACK. THE PATIENT WAS BEING TREATED ON THE RIGHT HIP FOR HIP PAIN. THE PATIENT WAS PLACED ON THEIR LEFT SIDE FOR THE TREATMENT. THE CLINICIAN APPLIED THE HOT PAC TO THE PATIENT'S RIGHT HIP. THE PACK WAS WRAPPED IN SIX LAYERS OF TOWELING AND APPLIED TO THE PATIENT. THE PATIENT INDICATED TO THE CLINICIAN THAT THEY FELT A HOT AREA ON THEIR LEFT SIDE. THE CLINICIAN THAT THEY FELT A HOT AREA ON THEIR LEFT SIDE. THE CLINICIAN TERMINATED THE TREATMENT, AND INSPECTED THE TREATMENT AREA AND THE PATIENT'S LEFT SIDE. THE PATIENT'S LEFT SIDE HAD A RED MARK ABOUT 1 INCH IN DIAMETER. THE MARK ON THE LEFT SIDE DID APPEAR TO BE A 2ND DEGREE BURN. A PATIENT'S RIGHT SIDE HAD NO MARKINGS FROM THE APPLICATION OF THE TREATMENT. THE CLINICIAN DID RENDER FIRST AID TO THE PATIENT WITH THE USE OF ANTISEPTIC AND GAUZE. THE PATIENT DID FOLLOW UP WITH THEIR PRIMARY CARE PHYSICIAN. UPON INSPECTION OF THE HOT PACK, THE CLINICIAN NOTED THAT THE PACK SEAM HAD SPLIT. THE CLINICIAN INDICATED THAT THE SPLIT IN THE SEAM ALLOWED THE CONTENTS OF THE PACK TO LEAK ONTO THE TREATMENT SURFACE, COMING INTO CONTACT WITH THE PATIENT'S LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEAM PAC STANDARD BOXED IMA CHATTANOOGA GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention