BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAREX INSTANT COLD PACK

    MDR report key: 6223732 · Received January 4, 2017

    Report

    Report Number
    2431014-2016-00002
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 27, 2016
    Report Date
    January 4, 2017
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    IMD
    UDI-DI
    00616784451213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT WE HAVE BEEN UNABLE TO DETERMINE IF THERE WAS PROPER PATIENT USE OF THE DEVICE AND IF THE DEVICE CAUSED ALLEGED BURNS DUE TO THE FAILURE/HOLE/BURSTING OF THE PACKAGING OR FROM DIRECT PLACEMENT OF THE DEVICE ON THE SKIN. INVESTIGATION IS SOMEWHAT HAMPERED BY INFORMATION BEING SUPPLIED BY THE ATTORNEY FOR THE PATIENT.

    Description of Event or Problem · 1

    WOMAN'S ATTORNEY DESCRIBED THE EVENT AS; "PLEASE BE ADVISED THAT OUR CLIENT SUSTAINED SERIOUS BURNS TO HER LOWER BACK AND BUTTOCKS AREA AND IS STILL UNDER ACTIVE MEDICAL CARE AND IT IS ANTICIPATED THAT THERE WILL BE PERMANENT SCARRING BUT WE WILL NEED TO CONTINUE TO MONITOR HER HEALING PROCESS." PRODUCT: DYNAREX COLD PACK, ITEM #: 4512, LOT: UNDETERMINED, NOT SUPPLIED AS YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4936 DYNAREX INSTANT COLD PACK INSTANT COLD PACK IMD DYNAREX CORPORATION 4512 00616784451213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention