BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAREX COLD PACK

    MDR report key: 4627534 · Received March 19, 2015

    Report

    Report Number
    MW5041579
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    January 28, 2015
    Report Date
    February 20, 2015
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER WRAPPED A SORE CALF WITH OUR COLD PACK FOR 20 MINUTES AND EXPERIENCED REDNESS AND A BURNING SENSATION. COLD PACK USED DURING THE INCIDENT WAS DISCARDED BUT ADDITIONAL SAMPLES ARE AVAILABLE FROM THE END USER FOR INSPECTION. DYNAREX GAVE HER A (B)(6) ACCT. TO USE ON (B)(6) 2015. DURING THE FOLLOW UP PHONE INTERVIEW WITH THE END USER SHE STATED THAT THE SAMPLES WERE SENT OUT ON (B)(6) 2015. FOLLOW-UP INTERVIEW WITH END USER ON (B)(6) 2015, USER REPORTED THAT SHE USED MOISTURIZER TO TREAT THE SKIN AND THAT NO MEDICAL INTERVENTION WAS NEEDED. NO PERMANENT SCARRING OR TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189244 DYNAREX COLD PACK COLD PACK IMD DYNAREX CORPORATION 4512 25194

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR