BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOT PACK, INSTANT

    MDR report key: 5762956 · Received June 30, 2016

    Report

    Report Number
    1417592-2016-00069
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 30, 2016
    Manufacturer
    RAPID AID CORP.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED A BURN TO THE BACK OF A LEG FOLLOWING THE APPLICATION OF A HOT PACK. WE HAVE NO OTHER INFORMATION PERTAINING TO THE INCIDENT. THE SEVERITY OF THE BURN OR NEED FOR MEDICAL INTERVENTION IS NOT KNOWN. A SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. WE HAVE NO INFORMATION TO INDICATE A DEFECT EXISTED. THE MANUFACTURER HAS BEEN NOTIFIED OF THIS INCIDENT. WE HAVE NOT CONFIRMED A SERIOUS INJURY RESULTED BUT IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    PATIENT SUFFERED A BURN FROM THE HOT PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416778 HOT PACK, INSTANT IMD RAPID AID CORP. CN16078

    Patients

    Seq Age Sex Outcome Treatment
    1 Other